Trial Outcomes & Findings for Belinostat and Carboplatin in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Carboplatin or Cisplatin (NCT NCT00993616)

Last Updated: 2019-07-23

Results Overview

Per Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (version 1.1): Complete Response (CR) is disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm; Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Increasing Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions); Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

29 participants

Primary outcome timeframe

From study entry, up to 5 years

Results posted on

2019-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses. belinostat: Given IV carboplatin: Given IV
Overall Study STARTED	29
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses. belinostat: Given IV carboplatin: Given IV
Overall Study No tumor at entry	1
Overall Study Never treated	1

Baseline Characteristics

Belinostat and Carboplatin in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Carboplatin or Cisplatin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=27 Participants Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses. belinostat: Given IV carboplatin: Given IV
Age, Continuous	61.2 years STANDARD_DEVIATION 6.8 • n=99 Participants
Age, Customized 40-49 years	2 participants n=99 Participants
Age, Customized 50-59 years	8 participants n=99 Participants
Age, Customized 60-69 years	15 participants n=99 Participants
Age, Customized 70-79 years	2 participants n=99 Participants
Sex: Female, Male Female	27 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment United States	27 participants n=99 Participants
Cell Type Adenocarcinoma, Unspecified	1 participants n=99 Participants
Cell Type Clear Cell Carcinoma	2 participants n=99 Participants
Cell Type Mixed Epithelial Carcinoma	1 participants n=99 Participants
Cell Type Serous Adenocarcinoma	23 participants n=99 Participants

PRIMARY outcome

Timeframe: From study entry, up to 5 years

Outcome measures

Outcome measures
Measure	Treatment n=27 Participants Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses. belinostat: Given IV carboplatin: Given IV	Grade 1 Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Grade 4 Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Grade 5 Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1) Complete Response	1 participants	—	—	—	—	—
Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1) Increase Disease	8 participants	—	—	—	—	—
Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1) Partial Response	1 participants	—	—	—	—	—
Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1) Stable Disease	12 participants	—	—	—	—	—
Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria (Version 1.1) Indeterminate	5 participants	—	—	—	—	—

PRIMARY outcome

Timeframe: Every cycle during treatment and 30 days after the end of treatment

Population: Eligible and treated patients

Outcome measures

Outcome measures
Measure	Treatment n=27 Participants Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses. belinostat: Given IV carboplatin: Given IV	Grade 1 n=27 Participants Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 n=27 Participants Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 n=27 Participants Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Grade 4 n=27 Participants Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Grade 5 n=27 Participants Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Leukopenia	12 Participants	5 Participants	9 Participants	1 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Thrombocytopenia	14 Participants	5 Participants	4 Participants	2 Participants	2 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Neutropenia	13 Participants	2 Participants	6 Participants	4 Participants	2 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Anemia	6 Participants	10 Participants	9 Participants	2 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Other hematologic	26 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Allergy/immunology	23 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Auditory/ear	26 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Cardiac	26 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Coagulation	25 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Constitutional	10 Participants	10 Participants	6 Participants	1 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Dermatologic	22 Participants	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Endocrine	26 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Nausea	6 Participants	14 Participants	5 Participants	2 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Vomiting	14 Participants	9 Participants	1 Participants	3 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Gastrointestinal	10 Participants	8 Participants	7 Participants	2 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Genitourinary/renal	26 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Hemorrhage	25 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Lymphatics	26 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Metabolic	17 Participants	7 Participants	1 Participants	2 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Musculoskeletal	25 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Neurosensory	21 Participants	5 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Other neurological	22 Participants	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Ocular/visual	26 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Pain	15 Participants	8 Participants	4 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Pulmonary	21 Participants	6 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Frequency and Severity of Observed Adverse Effects Graded According to NCI CTCAE Version 3.0 Vascular	25 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Every other cycle for 6 months

Population: Eligible and treated patients

Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Treatment n=27 Participants Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses. belinostat: Given IV carboplatin: Given IV	Grade 1 Number of patients who experienced a grade 1 event using Common Terminology Criteria version 3.0	Grade 2 Number of patients who experienced a grade 2 event using Common Terminology Criteria version 3.0	Grade 3 Number of patients who experienced a grade 3 event using Common Terminology Criteria version 3.0	Grade 4 Number of patients who experienced a grade 4 event using Common Terminology Criteria version 3.0	Grade 5 Number of patients who experienced a grade 5 event using Common Terminology Criteria version 3.0
Progression Free Survival at 6 Months	29.6 percentage of participants	—	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 5 years

Population: Please note: this outcome measure is not an endpoint as per the protocol document. Data will not be reported.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 9 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=27 participants at risk Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses. belinostat: Given IV carboplatin: Given IV
Immune system disorders Allergic Reaction/Hypersensitivity	3.7% 1/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Blood and lymphatic system disorders Platelets	3.7% 1/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Gastrointestinal disorders Obstruction, Gastrointestinal - Small Bowel Not otherwise specified	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Gastrointestinal disorders Dehydration	3.7% 1/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Vascular disorders Hemorrhage, Gastrointestinal - Upper Gastrointestinal Not Otherwise Specified	3.7% 1/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Infections and infestations Infection with normal or Grade 1 Or 2 Absolute neutrophil count: Blood	3.7% 1/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Nervous system disorders Somnolence	3.7% 1/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Respiratory, thoracic and mediastinal disorders Aspiration	3.7% 1/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.

Other adverse events

Other adverse events
Measure	Treatment n=27 participants at risk Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses. belinostat: Given IV carboplatin: Given IV
Immune system disorders Allergic Reaction/Hypersensitivity	11.1% 3/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Blood and lymphatic system disorders Neutrophils	55.6% 15/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Blood and lymphatic system disorders Platelets	44.4% 12/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Blood and lymphatic system disorders Leukocytes	55.6% 15/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Blood and lymphatic system disorders Hemoglobin	77.8% 21/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Cardiac disorders Palpitations	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Vascular disorders Partial thromboplastin time	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
General disorders Weight Gain	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
General disorders Fatigue	66.7% 18/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
General disorders Insomnia	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Skin and subcutaneous tissue disorders Flushing	14.8% 4/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Endocrine disorders Hot Flashes	14.8% 4/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Gastrointestinal disorders Distention	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Gastrointestinal disorders Mucositis (Functional/Symptomatic) - Oral Cavity	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Gastrointestinal disorders Obstruction, Gastrointestinal - Small Bowel Not otherwise specified	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Gastrointestinal disorders Vomiting	48.1% 13/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Gastrointestinal disorders Anorexia	33.3% 9/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Gastrointestinal disorders Constipation	37.0% 10/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Gastrointestinal disorders Nausea	77.8% 21/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Gastrointestinal disorders Diarrhea	22.2% 6/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Metabolism and nutrition disorders Creatinine	18.5% 5/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Metabolism and nutrition disorders Hypoalbuminemia	14.8% 4/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Metabolism and nutrition disorders Hypermagnesemia	11.1% 3/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Metabolism and nutrition disorders Hyponatremia	11.1% 3/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Metabolism and nutrition disorders Hypocalcemia	11.1% 3/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Metabolism and nutrition disorders Hyperglycemia	22.2% 6/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Metabolism and nutrition disorders Hypokalemia	14.8% 4/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Metabolism and nutrition disorders Hypomagnesemia	25.9% 7/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Musculoskeletal and connective tissue disorders Muscle Weakness - Whole Body/Generalized	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Nervous system disorders Mood Alteration - Depression	14.8% 4/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Nervous system disorders Neuropathy-Sensory	40.7% 11/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Eye disorders Blurred Vision	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
General disorders Pain: Head/Headache	22.2% 6/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
General disorders Pain: Abdominal Pain Not otherwise specified	25.9% 7/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
General disorders Pain: Muscle	11.1% 3/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Respiratory, thoracic and mediastinal disorders Cough	14.8% 4/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.2% 6/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.
Vascular disorders Thrombosis/Thrombus/Embolism	7.4% 2/27 • From study entry up to 5 years From the period of protocol activation through September 30, 2011, Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (CTCAE v3.0) are utilized. (9/26/11) Beginning October 1, 2011, the NCI Common Terminology Criteria for Adverse Events (CTCAE) v 4.0 will be utilized.

Additional Information

Melissa Leventhal

Gynecologic Oncology Group Statistical and Data Center

Phone: 716-845-4030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60