Trial · NCT01468909

Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer

NCT01468909, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2019-04-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer. Trials, record NCT01468909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01468909

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Trial

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

Title: Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
NCT number: NCT01468909
Status: Completed
Phases: Phase 2
Enrollment: 106 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
Interventions: Laboratory Biomarker Analysis, Paclitaxel, Pazopanib Hydrochloride, Placebo
First posted: 2011-11-10
Last updated: 2019-07-23
Results first posted: 2019-04-16

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Progression Free Survival	For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years	The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Secondary	Adverse Events as Assessed by CTCAE v.4	From baseline to 30 days after last dose of drug.	All grade 3 or greater Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Secondary	Proportion of Participants With Tumor Response by RECIST	Every other cycle for 6 months, then every 3 months until disease progression,Up to 5 years	Patients with Complete and Partial Tumor Response by RECIST 1.1. Responses (CR and PR) require confirmation at greater than or equal to 4 weeks from initial documentation. 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	Percentage of Participants With Tumor Response by CA-125	Prior to each cycle of treatment. Then follow-up every three months for 2 years and then every 6 months for 3 years, up to 5 years.	Response as evaluated by CA-125 levels. Response is indicated if CA-125 reduced by 50% of the baseline measure.
Secondary	Overall Survival (OS)	Every cycle while patient is receiving protocol therapy. Patients monitored for survival after off therapy every 3 months for 2 years, then every 6 months, up to 5 years	Overall survival
Other	Single-nucleotide Polymorphisms, Assessed Using the iPLEX Assay on the Sequenome MassARRAY Platform	Up to 5 years	Analyzed using deoxyribonucleic acid isolated from whole blood specimens.

Source ClinicalTrials.gov

Outcomes6

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression Free Survival	For those patients whose disease can be evaluated by physical examination, progression was assessed prior to each 21-day cycle. CT scan or MRI if used to follow lesion for measurable disease every other cycle, Up to 5 years	All randomized patients	months	MEDIAN
SECONDARY	Adverse Events as Assessed by CTCAE v.4	From baseline to 30 days after last dose of drug.	Treated and eligible patients	participants	NUMBER
SECONDARY	Proportion of Participants With Tumor Response by RECIST	Every other cycle for 6 months, then every 3 months until disease progression,Up to 5 years	All randomized patients.	proportion of participants	NUMBER
SECONDARY	Percentage of Participants With Tumor Response by CA-125	Prior to each cycle of treatment. Then follow-up every three months for 2 years and then every 6 months for 3 years, up to 5 years.	CA-125 Evaluable patients	percentage of participants	NUMBER
SECONDARY	Overall Survival (OS)	Every cycle while patient is receiving protocol therapy. Patients monitored for survival after off therapy every 3 months for 2 years, then every 6 months, up to 5 years	All randomized patients.	months	MEDIAN
OTHER_PRE_SPECIFIED	Single-nucleotide Polymorphisms, Assessed Using the iPLEX Assay on the Sequenome MassARRAY Platform	Up to 5 years

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Progression Free Survival	Paclitaxel + Placebo	6.2	95% Confidence Interval 5.5 to 8.5	months
Progression Free Survival	Paclitaxel + Pazopanib	7.5	95% Confidence Interval 5.3 to 9.1	months
Adverse Events as Assessed by CTCAE v.4	Paclitaxel + Placebo	18	95% Confidence Interval 11 to 26	participants
Adverse Events as Assessed by CTCAE v.4	Paclitaxel + Pazopanib	45	95% Confidence Interval 38 to 49	participants
Proportion of Participants With Tumor Response by RECIST	Paclitaxel + Placebo	0.192	95% Confidence Interval 0.096 to 0.325	proportion of participants
Proportion of Participants With Tumor Response by RECIST	Paclitaxel + Pazopanib	0.259	95% Confidence Interval 0.150 to 0.397	proportion of participants
Percentage of Participants With Tumor Response by CA-125	Paclitaxel + Placebo	41	95% Confidence Interval 24 to 59	percentage of participants
Percentage of Participants With Tumor Response by CA-125	Paclitaxel + Pazopanib	72	95% Confidence Interval 55 to 85	percentage of participants
Overall Survival (OS)	Paclitaxel + Placebo	23.3	90% Confidence Interval 17.3 to NA	months
Overall Survival (OS)	Paclitaxel + Pazopanib	20.7	90% Confidence Interval 17.0 to 22.6	months

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Paclitaxel + Placebo	52
Overall Study	STARTED	Paclitaxel + Pazopanib	54
Overall Study	COMPLETED	Paclitaxel + Placebo	50
Overall Study	COMPLETED	Paclitaxel + Pazopanib	52
Overall Study	NOT COMPLETED	Paclitaxel + Placebo	2
Overall Study	NOT COMPLETED	Paclitaxel + Pazopanib	2

Source ClinicalTrials.gov

Adverse events486

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	Lymph Node Pain	Blood and lymphatic system disorders	Paclitaxel + Placebo	3	50
other	Lymph Node Pain	Blood and lymphatic system disorders	Paclitaxel + Pazopanib	0	52
other	Anemia	Blood and lymphatic system disorders	Paclitaxel + Placebo	46	50
other	Anemia	Blood and lymphatic system disorders	Paclitaxel + Pazopanib	48	52
other	Febrile Neutropenia	Blood and lymphatic system disorders	Paclitaxel + Placebo	0	50
other	Febrile Neutropenia	Blood and lymphatic system disorders	Paclitaxel + Pazopanib	1	52
other	Atrial Fibrillation	Cardiac disorders	Paclitaxel + Placebo	1	50
other	Atrial Fibrillation	Cardiac disorders	Paclitaxel + Pazopanib	0	52
other	Sinus Bradycardia	Cardiac disorders	Paclitaxel + Placebo	1	50
other	Sinus Bradycardia	Cardiac disorders	Paclitaxel + Pazopanib	0	52

1 to 10 of 486Source ClinicalTrials.gov

See all 486 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Paclitaxel + Placebo	20	50
Total, all-cause mortality	Paclitaxel + Pazopanib	23	52
Total, other adverse events	Paclitaxel + Placebo	50	50
Total, other adverse events	Paclitaxel + Pazopanib	51	52
Total, serious adverse events	Paclitaxel + Placebo	15	50
Total, serious adverse events	Paclitaxel + Pazopanib	22	52

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29242937	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 comparisons3

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

Comparison	Source
Paclitaxel + Placebo vs Paclitaxel + Pazopanib: Adverse Events as Assessed by CTCAE v.4	Trial comparisons
Paclitaxel + Placebo vs Paclitaxel + Pazopanib: deaths from any cause	Trial comparisons
Paclitaxel + Placebo vs Paclitaxel + Pazopanib: serious adverse events	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/NCT01468909

GET https://conductscience.org/api/trials/v1/NCT01468909/events?page=2

API reference For AI assistants