Trial Outcomes & Findings for Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer (NCT NCT01716715)

Last Updated: 2020-03-10

Results Overview

Time from patient entry until progression, death, or beginning a subsequent therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

111 participants

Primary outcome timeframe

The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks

Results posted on

2020-03-10

Participant Flow

111 patients were enrolled from November 6, 2012 to May 5, 2014

Participant milestones

Participant milestones
Measure	Cabozantinib Cabozantinib 60 mg oral daily continously	Paclitaxel Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Overall Study STARTED	57	54
Overall Study COMPLETED	55	50
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cabozantinib Cabozantinib 60 mg oral daily continously	Paclitaxel Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Overall Study Never Treated	2	4

Baseline Characteristics

Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cabozantinib n=57 Participants Cabozantinib 60 mg oral daily continously	Paclitaxel n=54 Participants Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15	Total n=111 Participants Total of all reporting groups
Age, Customized 20-29 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Customized 30-39 years	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Age, Customized 40-49 years	5 Participants n=99 Participants	4 Participants n=107 Participants	9 Participants n=206 Participants
Age, Customized 50-59 years	21 Participants n=99 Participants	19 Participants n=107 Participants	40 Participants n=206 Participants
Age, Customized 60-69 years	20 Participants n=99 Participants	24 Participants n=107 Participants	44 Participants n=206 Participants
Age, Customized 70-79 years	9 Participants n=99 Participants	6 Participants n=107 Participants	15 Participants n=206 Participants
Age, Customized >=80 years	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Sex: Female, Male Female	57 Participants n=99 Participants	54 Participants n=107 Participants	111 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	4 Participants n=99 Participants	2 Participants n=107 Participants	6 Participants n=206 Participants
Race (NIH/OMB) White	50 Participants n=99 Participants	48 Participants n=107 Participants	98 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants

PRIMARY outcome

Timeframe: The duration of time from study entry to time to progression or death,or begining a subsequent therapy, whichever occurs first, assessed up to 32 weeks

Population: Enrolled Patients

Outcome measures

Outcome measures
Measure	Cabozantinib n=57 Participants Cabozantinib 60 mg oral daily continously	Paclitaxel n=54 Participants Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Event Free Survival	3.48 months Interval 2.79 to 4.07	4.96 months Interval 3.71 to 5.72

SECONDARY outcome

Timeframe: Up to 30 days after completion of study treatment

Population: Eligible and Treated participants

Toxicities will be characterized by their frequency and severity, grade 3 and above.

Outcome measures

Outcome measures
Measure	Cabozantinib n=55 Participants Cabozantinib 60 mg oral daily continously	Paclitaxel n=50 Participants Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Number of Participants With Grade 3 or Higher Adverse Events by Type Neutropenia	2 Participants	4 Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type Anemia	4 Participants	0 Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type Gastrointestinal	15 Participants	2 Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type Metabolism/nutrition	10 Participants	3 Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type Musculoskeletal/connective tissue	1 Participants	0 Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type Nervous System	3 Participants	0 Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type Renal/Urinary	1 Participants	0 Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type Respiratory/thoracic/mediastinal	3 Participants	1 Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type Skin/subcutaneous	2 Participants	0 Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type Vascular disorders	12 Participants	5 Participants

SECONDARY outcome

Timeframe: CT or MRI used to follow lesion every 8 weeks for the first 8 months, then every 12 weeks until disease progression, approximately 2.5 years

Population: All enrolled participants

Complete and Partial Tumor Response by RECIST. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure	Cabozantinib n=57 Participants Cabozantinib 60 mg oral daily continously	Paclitaxel n=54 Participants Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Response, Assessed According to RECIST Version 1.1	7.02 percentage of participants Interval 2.4 to 15.3	24.07 percentage of participants Interval 14.9 to 35.5

SECONDARY outcome

Timeframe: Prior to each cycle of treatment. Then follow-up every 3 months for 2 years then then every 6 months, up to 2.5 years.

Population: Participants evaluable by CA125

Complete and Partial Tumor Response by CA125. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",

Outcome measures

Outcome measures
Measure	Cabozantinib n=34 Participants Cabozantinib 60 mg oral daily continously	Paclitaxel n=29 Participants Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Percentage of Participants With CA125 Response.	29.4 percentage of participants Interval 16.9 to 44.8	58.6 percentage of participants Interval 41.7 to 74.1

SECONDARY outcome

Timeframe: The duration of time from study entry to time of death or the date of last contact, an average of 2.5 years.

Population: All enrolled participants

The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored.

Outcome measures

Outcome measures
Measure	Cabozantinib n=57 Participants Cabozantinib 60 mg oral daily continously	Paclitaxel n=54 Participants Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Overall Survival	19.4 months Interval 12.3 to Upper limit of confidence interval has not been reached	NA months Interval 16.0 to The median and upper limit of confidence interval has not been reached

SECONDARY outcome

Timeframe: From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented or date of death from any cause, whichever came first, assessed up to 18 months.

Population: Patients who respond.

The time participant is in response.Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",

Outcome measures

Outcome measures
Measure	Cabozantinib n=4 Participants Cabozantinib 60 mg oral daily continously	Paclitaxel n=13 Participants Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
To Estimate the Response Duration Among Patients Who Respond.	3.8 months Interval 0.1 to 4.3	7.4 months Interval 3.5 to 16.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Outcome measures

Outcome data not reported

Adverse Events

Cabozantinib

Serious events: 25 serious events

Other events: 55 other events

Deaths: 0 deaths

Paclitaxel

Serious events: 8 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Linda Gedeon on behalf of Michael Sill, PhD.

NRG Oncology

Phone: 716-845-1169

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Cabozantinib n=55 participants at risk Cabozantinib 60 mg oral daily continously	Paclitaxel n=50 participants at risk Paclitaxel 80mg/m2 administered weekly on days 1, 8 and 15
Gastrointestinal disorders Diarrhea	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Gastrointestinal disorders Small Intestinal Perforation	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Gastrointestinal disorders Small Intestinal Obstruction	3.6% 2/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Gastrointestinal disorders Abdominal Pain	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	4.0% 2/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Gastrointestinal disorders Mucositis Oral	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Gastrointestinal disorders Anal Pain	3.6% 2/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Gastrointestinal disorders Ileal Obstruction	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
General disorders Pain	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
General disorders Fever	0.00% 0/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	4.0% 2/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Injury, poisoning and procedural complications Wound Complication	3.6% 2/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Investigations Lipase Increased	3.6% 2/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Investigations Aspartate Aminotransferase Increased	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Investigations Alanine Aminotransferase Increased	3.6% 2/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Metabolism and nutrition disorders Hyponatremia	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Metabolism and nutrition disorders Hypomagnesemia	3.6% 2/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	2.0% 1/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Metabolism and nutrition disorders Hyperkalemia	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms Benign, Malignant And Unspecified (Incl	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Nervous system disorders Memory Impairment	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Nervous system disorders Dizziness	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary Hypertension	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	2.0% 1/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Skin and subcutaneous tissue disorders Palmar-Plantar Erythrodysesthesia Syndrome	1.8% 1/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Vascular disorders Thromboembolic Event	7.3% 4/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	4.0% 2/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.
Vascular disorders Hypertension	3.6% 2/55 • During study treatment through 30 days after treatment ends, an average of 2.5 years.	0.00% 0/50 • During study treatment through 30 days after treatment ends, an average of 2.5 years.