Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor - Protocol SpecificBreast Cancer - Female
- Interventions
- Registration Number
- NCT01407562
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief Summary
This is an open label, dose escalation study to determine the safety and tolerability and maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors.
- Detailed Description
This is an open label, dose escalation study to determine the maximum tolerated dose (MTD) of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors. There will be a dose expansion cohort of thirty patients to assess detailed pharmacokinetics and to assess any signal of activity in patients with solid tumors and in a portion who have breast cancer that is triple negative (ER-negative, PR-negative, and HER2-negative).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 34
- Confirmed diagnosis of a solid malignancy with advanced disease that has relapsed, that is refractory to standard therapies, or for which there is not standard therapy, or for which the patient opts not to receive standard therapy.
- At the recommended phase II dose level, triple-negative breast cancer defined as ER-negative, PR-negative, and HER2-negative, will be enrolled and another 10 patients with a solid malignancy who would benefit from a paclitaxel and carboplatin-based regimen, will also be enrolled.
- Male or female ≥ 18 years of age
- Able to swallow and retain oral medications
- Major surgery within last 28 days or cytotoxic chemotherapy, biologic therapy, investigational agents, or radiotherapy within last 21 days. Patients who have completed therapy with mitomycin C or nitrosurea will have to wait 42 days.
- More than 3 prior lines of cytotoxic chemotherapy for metastatic disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pazopanib with paclitaxel and carboplatin Pazopanib - Pazopanib with paclitaxel and carboplatin Carboplatin - Pazopanib with paclitaxel and carboplatin Paclitaxel -
- Primary Outcome Measures
Name Time Method Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle 4 years, 6 months Toxicity will be assessed every 28 days up to 30 days after the last dose of treatment. Dose limiting toxicity is defined as
1. Non-hematological toxicity ≥ grade 3 (excluding alopecia, nausea, vomiting, or diarrhea for which adequate supportive therapy has not been instituted).
2. Hematologic toxicity:
* Grade 4 neutropenia lasting ≥ 7 days
* Grade 4 neutropenia and fever of ≥ 38.5°C
* ≥ Grade 3 neutropenia with ≥ Grade 3 infection
* Grade 4 thrombocytopenia
* Inability to start next cycle of treatment by more than 4 weeks due to unresolved toxicity
- Secondary Outcome Measures
Name Time Method Determine the drug-drug interactions with paclitaxel, carboplatin, and pazopanib 4 years, 3 months The first 15 patients enrolled in the dose expansion cohort will undergo PK sampling as this is felt to be an adequate sample size.
4 blood samples (2 mL each) for the analysis of paclitaxel will be obtained in Cycle 1 Day 1 and Cycle 2 Day 1
2 blood samples (2 mL each) for the analysis of carboplatin will be obtained in Cycle 1 Day 1 and Cycle 2 Day 1
1 blood sample (2 mL) for the analysis of pazopanib will be collected in Cycle 2 Day 1
Trial Locations
- Locations (1)
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States