Paclitaxel With or Without Pazopanib Hydrochloride in Treating Patients With Persistent or Recurrent Ovarian Epithelial, Fallopian Tube, or Peritoneal Cavity Cancer
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|ClinicalTrials.gov Identifier: NCT01468909|
Recruitment Status : Completed
First Posted : November 10, 2011
Last Update Posted : June 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Fallopian Tube Carcinoma Recurrent Ovarian Carcinoma Recurrent Primary Peritoneal Carcinoma||Other: Laboratory Biomarker Analysis Drug: Paclitaxel Drug: Pazopanib Hydrochloride Other: Placebo||Phase 2|
I. To estimate the progression-free survival hazard ratio of the combination of weekly paclitaxel and pazopanib (pazopanib hydrochloride) compared to weekly paclitaxel and placebo in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer.
I. To determine the frequency and severity of adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE).
II. To estimate and compare the proportion of patients responding to therapy by Response Evaluation Criteria in Solid Tumors (RECIST), cancer antigen 125 (CA125) response, the overall survival (OS), and the duration of response in each arm.
I. To explore the association between plasma cytokines and angiogenic markers and progression-free and overall survival.
II. To explore the association between single-nucleotide polymorphisms (SNPs) and progression-free and overall survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 and placebo orally (PO) daily on days 1-28.
ARM II: Patients receive paclitaxel as in Arm I and pazopanib hydrochloride PO daily on days 1-28.
In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||111 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Phase IIB Evaluation of Weekly Paclitaxel (NSC #673089) Plus Pazopanib (NSC #737754) Versus Weekly Paclitaxel Plus Placebo in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma|
|Actual Study Start Date :||December 12, 2011|
|Actual Primary Completion Date :||January 27, 2018|
|Actual Study Completion Date :||January 27, 2018|
Placebo Comparator: Arm I (paclitaxel and placebo)
Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Experimental: Arm II (paclitaxel and pazopanib hydrochloride)
Patients receive paclitaxel as in arm I and pazopanib hydrochloride PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Drug: Pazopanib Hydrochloride
- Efficacy of each treatment regimen [ Time Frame: Up to 5 years ]Evaluated using the Cox proportional hazards and stratified by platinum-free interval, measurable disease status, and prior use of bevacizumab. Maximum likelihood estimate of the logarithm of the hazard ratio of Arm 2 to Arm 1 for disease progression or death (PFS endpoint) will be calculated.
- Adverse events as assessed by CTCAE [ Time Frame: Up to 30 days after completion of study treatment ]Toxicities will be characterized by their frequency and severity. Differences in the level of toxicities by treatment regimen will be assessed by classifying them as severe or not severe and examining the relative proportion of severe toxicities.
- Frequency and duration of tumor response by RECIST, including CA-125 status [ Time Frame: Up to 5 years ]The effects of treatment on the proportion responding by RECIST and possibly by CA125 will be examined. An examination of response by CA125 (stratified by treatment) will also be conducted in those patients who have measurable disease to assess the level of agreement between the two methods of evaluation. The impact of additional, various prognostic factors or biological markers will be examined with exploratory analyses including log-rank tests with characterization with hazard ratio estimates.
- Overall survival (OS) [ Time Frame: Up to 5 years ]Differences between measurable versus non-measurable disease status on OS will be examined with plots of survival curves, estimates of quartiles and hazard ratios.
- Plasma cytokines and angiogenic markers [ Time Frame: Up to 20 weeks ]Plasma specimens should be prepared from blood drawn prior to course 1, prior to course 2, and prior to course 3 of therapy.
- Single-nucleotide polymorphisms, assessed using the iPLEX assay on the Sequenome MassARRAY platform [ Time Frame: Up to 5 years ]Analyzed using deoxyribonucleic acid isolated from whole blood specimens.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01468909
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|Principal Investigator:||Debra Richardson||NRG Oncology|