Trial · NCT01716715

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

NCT01716715, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2020-03-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer. Trials, record NCT01716715. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01716715

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Cabozantinib or Paclitaxel in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
NCT number: NCT01716715
Status: Completed
Phases: Phase 2
Enrollment: 111 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Interventions: Cabozantinib S-malate, Laboratory Biomarker Analysis, Paclitaxel
First posted: 2012-10-30
Last updated: 2020-03-10
Results first posted: 2020-03-10

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Event Free Survival	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	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.",
Secondary	Number of Participants With Grade 3 or Higher Adverse Events by Type	Up to 30 days after completion of study treatment	Toxicities will be characterized by their frequency and severity, grade 3 and above.
Secondary	Response, Assessed According to RECIST Version 1.1	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	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
Secondary	Percentage of Participants With CA125 Response.	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.	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.",
Secondary	Overall Survival	The duration of time from study entry to time of death or the date of last contact, an average of 2.5 years.	The time from randomization until death or date of last contact. Endpoint is death. Patients who are not observed with an endpoint are censored.
Secondary	To Estimate the Response Duration Among Patients Who Respond.	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.	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.",
Other	c-Met Expression	Baseline
Other	c-MET Copy Number	Baseline

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Event Free Survival	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	Enrolled Patients	months	MEDIAN
SECONDARY	Number of Participants With Grade 3 or Higher Adverse Events by Type	Up to 30 days after completion of study treatment	Eligible and Treated participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Response, Assessed According to RECIST Version 1.1	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	All enrolled participants	percentage of participants	NUMBER
SECONDARY	Percentage of Participants With CA125 Response.	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.	Participants evaluable by CA125	percentage of participants	NUMBER
SECONDARY	Overall Survival	The duration of time from study entry to time of death or the date of last contact, an average of 2.5 years.	All enrolled participants	months	MEDIAN
SECONDARY	To Estimate the Response Duration Among Patients Who Respond.	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.	Patients who respond.	months	MEDIAN
OTHER_PRE_SPECIFIED	c-Met Expression	Baseline
OTHER_PRE_SPECIFIED	c-MET Copy Number	Baseline

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Event Free Survival	Cabozantinib		3.48	95% Confidence Interval 2.79 to 4.07	months
Event Free Survival	Paclitaxel		4.96	95% Confidence Interval 3.71 to 5.72	months
Number of Participants With Grade 3 or Higher Adverse Events by Type	Grade 3 and Above on Cabozantinib	Neutropenia	2		Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type	Grade 3 and Above on Paclitaxel	Neutropenia	4		Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type	Grade 3 and Above on Cabozantinib	Anemia	4		Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type	Grade 3 and Above on Paclitaxel	Anemia	0		Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type	Grade 3 and Above on Cabozantinib	Gastrointestinal	15		Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type	Grade 3 and Above on Paclitaxel	Gastrointestinal	2		Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type	Grade 3 and Above on Cabozantinib	Metabolism/nutrition	10		Participants
Number of Participants With Grade 3 or Higher Adverse Events by Type	Grade 3 and Above on Paclitaxel	Metabolism/nutrition	3		Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cabozantinib	57
Overall Study	STARTED	Paclitaxel	54
Overall Study	COMPLETED	Cabozantinib	55
Overall Study	COMPLETED	Paclitaxel	50
Overall Study	NOT COMPLETED	Cabozantinib	2
Overall Study	NOT COMPLETED	Paclitaxel	4

Source ClinicalTrials.gov

Adverse events448

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Cabozantinib	23	55
other	Anemia	Blood and lymphatic system disorders	Paclitaxel	46	50
other	Sinus Bradycardia	Cardiac disorders	Cabozantinib	1	55
other	Sinus Bradycardia	Cardiac disorders	Paclitaxel	1	50
other	Palpitations	Cardiac disorders	Cabozantinib	2	55
other	Palpitations	Cardiac disorders	Paclitaxel	0	50
other	Atrioventricular Block First Degree	Cardiac disorders	Cabozantinib	1	55
other	Atrioventricular Block First Degree	Cardiac disorders	Paclitaxel	0	50
other	Cardiac Disorders - Other	Cardiac disorders	Cabozantinib	1	55
other	Cardiac Disorders - Other	Cardiac disorders	Paclitaxel	0	50

1 to 10 of 448Source ClinicalTrials.gov

See all 448 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cabozantinib
Total, all-cause mortality	Paclitaxel
Total, other adverse events	Cabozantinib	55	55
Total, other adverse events	Paclitaxel	50	50
Total, serious adverse events	Cabozantinib	25	55
Total, serious adverse events	Paclitaxel	8	50

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
30587441	DERIVED	PubMed
37185961	DERIVED	PubMed

Grants2

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source
U10CA180868	NRG Oncology Network Group Operations Center	WOLMARK, NORMAN; Le, Quynh-Thu Xuan; MANNEL, ROBERT S.	NRG ONCOLOGY FOUNDATION, INC.	NATIONAL CANCER INSTITUTE	2014 to 2026	NIH RePORTER
U10CA027469	Gynecologic Oncology Group	DISAIA, PHILIP J.	GYNECOLOGIC ONCOLOGY GROUP	NATIONAL CANCER INSTITUTE	1985 to 2013	NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Cabozantinib vs Paclitaxel: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01716715

GET https://conductscience.org/api/trials/v1/NCT01716715/results?page=2

API reference For AI assistants