Pazopanib Hydrochloride, Paclitaxel, and Carboplatin in Treating Patients With Refractory or Resi… (NCT01402271) | Clinical Trial Compass
CompletedPhase 1/2
Pazopanib Hydrochloride, Paclitaxel, and Carboplatin in Treating Patients With Refractory or Resistant Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Peritoneal Cancer
RATIONALE: Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of pazopanib hydrochloride when given together with paclitaxel and carboplatin in treating patients with refractory or resistant ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal carcinoma
* Recurrent disease
* Received at least 1 prior platinum treatment and developed platinum-refractory disease (i.e., progression within 4 weeks of platinum administration) or platinum-resistant disease (i.e., progression within 6 months after the last platinum dose)
* There is no restriction on the number of prior lines of treatment
* Non-platinum treatment is allowed after proven platinum-resistance or -refractory disease
* Evaluable (measurable or nonmeasurable) disease according to RECIST version 1.1 criteria
* Patients with refractory disease on weekly paclitaxel and carboplatin regimen are excluded (phase II only)
* No known gastrointestinal intraluminal metastatic lesions with risk of bleeding
* No known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
* No known brain metastases or leptomeningeal disease
PATIENT CHARACTERISTICS:
* WHO performance status 0-2
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Hemoglobin ≥ 9 g/dL
* Platelet count ≥ 100 x 10\^9/L
* PT, aPTT, or INR ≤ 1.2 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN\*
* ALT and AST ≤ 2.5 times ULN\*
* Serum creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance ≥ 50 mL/min
* Urine protein creatinine ratio \< 1 OR 24-hour urine protein \< 1 g
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraceptio…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum-tolerated dose of pazopanib hydrochloride, carboplatin, and paclitaxel (phase I)
2
Progression-free survival according to RECIST 1.1 at 1 year (phase II)
Trial details
NCT IDNCT01402271
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC