Trial Outcomes & Findings for Sunitinib Malate in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer (NCT NCT00388037)

Last Updated: 2015-01-27

Results Overview

Partial response is defined as a 30% decrease in the sum of the longest diameters of the target lesion maintained for at least 4 weeks; complete response is defined as complete disappearance of disease and cancer related symptoms maintained for at least 4 weeks. The 95% confidence interval for response rate will be calculated. The median and range of the duration of response will be assessed.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

31 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2015-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Sunitinib Malate) Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO laboratory biomarker analysis: Correlative studies
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Sunitinib Malate) Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO laboratory biomarker analysis: Correlative studies
Overall Study Protocol Violation	1

Baseline Characteristics

Sunitinib Malate in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Sunitinib Malate) n=30 Participants Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO laboratory biomarker analysis: Correlative studies
Age, Continuous	57 years n=99 Participants
Sex: Female, Male Female	30 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Region of Enrollment Canada	30 participants n=99 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: All response evaluable patients

Outcome measures

Outcome measures
Measure	Treatment (Sunitinib Malate) n=28 Participants Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO laboratory biomarker analysis: Correlative studies
Objective Response (Partial Response or Complete Response) as Per the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria	3.6 percentage of evalubale patients Interval 0.1 to 18.3

Adverse Events

Treatment (Sunitinib Malate)

Serious events: 15 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Sunitinib Malate) n=30 participants at risk Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO laboratory biomarker analysis: Correlative studies
Nervous system disorders Neuropathy-Sensory	3.3% 1/30
Eye disorders Dry eye	3.3% 1/30
Nervous system disorders Dizziness	6.7% 2/30
Cardiac disorders Cerebrovascular ischemia	3.3% 1/30
Investigations Hypomagnesemia	3.3% 1/30
General disorders Death- NOS	10.0% 3/30
Gastrointestinal disorders Distension/Bloating and Flatulence	3.3% 1/30
Eye disorders Watery eye	3.3% 1/30
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.3% 1/30
General disorders Pain-abdominal	10.0% 3/30
Gastrointestinal disorders Hospitalization for Vomiting	3.3% 1/30
Gastrointestinal disorders Small Bowel Obstruction	10.0% 3/30
Blood and lymphatic system disorders Anemia	3.3% 1/30
Renal and urinary disorders Renal Obstruction	3.3% 1/30
Gastrointestinal disorders Dysphagia	3.3% 1/30

Other adverse events

Other adverse events
Measure	Treatment (Sunitinib Malate) n=30 participants at risk Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. sunitinib malate: Given PO laboratory biomarker analysis: Correlative studies
Ear and labyrinth disorders Hearing (without monitoring program)	6.7% 2/30
Cardiac disorders Hypertension	50.0% 15/30
General disorders Fatigue	93.3% 28/30
General disorders Fever	10.0% 3/30
General disorders Insomnia	33.3% 10/30
General disorders Rigors/chills	20.0% 6/30
General disorders Sweating	6.7% 2/30
Skin and subcutaneous tissue disorders Alopecia	16.7% 5/30
Skin and subcutaneous tissue disorders Bruising	13.3% 4/30
Skin and subcutaneous tissue disorders Dry skin	13.3% 4/30
Skin and subcutaneous tissue disorders Hand-foot	43.3% 13/30
Skin and subcutaneous tissue disorders Hypopigmentation	13.3% 4/30
Skin and subcutaneous tissue disorders Pruritus	16.7% 5/30
Skin and subcutaneous tissue disorders Rash	33.3% 10/30
Skin and subcutaneous tissue disorders Dermatology - Other	26.7% 8/30
Endocrine disorders Hot flashes	13.3% 4/30
Endocrine disorders Hypothyroidism	13.3% 4/30
Gastrointestinal disorders Anorexia	43.3% 13/30
Gastrointestinal disorders Constipation	63.3% 19/30
Gastrointestinal disorders Diarrhea	53.3% 16/30
Gastrointestinal disorders Distension	53.3% 16/30
Gastrointestinal disorders Dry mouth	10.0% 3/30
Gastrointestinal disorders Dysphagia	6.7% 2/30
Gastrointestinal disorders Flatulence	6.7% 2/30
Gastrointestinal disorders Gastritis	6.7% 2/30
Gastrointestinal disorders Heartburn	60.0% 18/30
Gastrointestinal disorders Hemorrhoids	6.7% 2/30
Gastrointestinal disorders Mucositis (clinical exam) Oral cavity	56.7% 17/30
Gastrointestinal disorders Mucositis (functional/symptomatic) Oral cavity	23.3% 7/30
Gastrointestinal disorders Nausea	80.0% 24/30
Gastrointestinal disorders Obstruction, GI Small bowel NOS	6.7% 2/30
Gastrointestinal disorders Taste alteration	60.0% 18/30
Gastrointestinal disorders Vomiting	60.0% 18/30
Gastrointestinal disorders GI - Other	16.7% 5/30
Blood and lymphatic system disorders Hemorrhage, GI Rectum	16.7% 5/30
Blood and lymphatic system disorders Hemorrhage, GU Vagina	10.0% 3/30
Infections and infestations Infection with normal ANC Bladder	6.7% 2/30
Infections and infestations Infection with normal ANC Urinary tract NOS	10.0% 3/30
Infections and infestations Infection with unknown ANC Upper airway NOS	6.7% 2/30
Blood and lymphatic system disorders Edema: head and neck	16.7% 5/30
Blood and lymphatic system disorders Edema: limb	20.0% 6/30
Musculoskeletal and connective tissue disorders Muscle weakness Whole body/generalized	6.7% 2/30
Nervous system disorders Dizziness	23.3% 7/30
Nervous system disorders Mood alteration Anxiety	23.3% 7/30
Nervous system disorders Mood alteration Depression	13.3% 4/30
Nervous system disorders Neuropathy-sensory	50.0% 15/30
Nervous system disorders Syncope	6.7% 2/30
Eye disorders Blurred vision	10.0% 3/30
Eye disorders Watery eye	23.3% 7/30
Eye disorders Ocular - Other	6.7% 2/30
General disorders Pain Abdomen NOS	66.7% 20/30
General disorders Pain Back	43.3% 13/30
General disorders Pain Bladder	6.7% 2/30
General disorders Pain Extremity-limb	13.3% 4/30
General disorders Pain Head/headache	43.3% 13/30
General disorders Pain Joint	20.0% 6/30
General disorders Pain Muscle	20.0% 6/30
General disorders Pain Neck	6.7% 2/30
General disorders Pain Oral cavity	10.0% 3/30
General disorders Pain Pelvis	16.7% 5/30
General disorders Pain Rectum	6.7% 2/30
General disorders Pain Throat/pharynx/larynx	6.7% 2/30
General disorders Pain - Other	13.3% 4/30
Respiratory, thoracic and mediastinal disorders Cough	33.3% 10/30
Respiratory, thoracic and mediastinal disorders Dyspnea	40.0% 12/30
Renal and urinary disorders Incontinence, urinary	6.7% 2/30
Renal and urinary disorders Urinary frequency	16.7% 5/30
Renal and urinary disorders Urine color change	6.7% 2/30
Reproductive system and breast disorders Vaginal discharge	6.7% 2/30

Additional Information

Dr. James Biagi

Cancer Centre of Southeastern Ontario at Kingston

Phone: (613) 544-2630

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60