Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Unspecified Adult Solid Tumor - Protocol Specific Breast Cancer - Female |
Drug: Pazopanib Drug: Paclitaxel Drug: Carboplatin |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors |
- Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle [ Time Frame: Up to 30 days after last dose of treatment ] [ Designated as safety issue: Yes ]
Toxicity will be assessed every 28 days up to 30 days after the last dose of treatment. Dose limiting toxicity is defined as
- Non-hematological toxicity ≥ grade 3 (excluding alopecia, nausea, vomiting, or diarrhea for which adequate supportive therapy has not been instituted).
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
- Determine the drug-drug interactions with paclitaxel, carboplatin, and pazopanib [ Time Frame: Cycle 1 Day 1 and Cycle 2 Day 1 ] [ Designated as safety issue: No ]
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
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pazopanib with paclitaxel and carboplatin |
Drug: Pazopanib
Starting dose is 400 given on Days 2-5, 9-12, and 16-26 of each 28 day cycle
Drug: Paclitaxel
Starting dose is 60 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle
Drug: Carboplatin
Starting dose of carboplatin that corresponds to an AUC of 2, IV on days 1, 8, and 15 of each 28 day cycle
|
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 triplenegative (ER-negative, PR-negative, and HER2-negative).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: CINJ Clinical Trials Office | 732-235-8675 |
| United States, New Jersey | |
| Cancer Institute of New Jersey | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| Principal Investigator: | Antoinette Tan, MD | University of Medicine and Dentisty of New Jersey - Cancer Institute of New Jersey |
More Information
No publications provided
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT01407562 History of Changes |
| Other Study ID Numbers: | 051101, P30CA072720 |
| Study First Received: | July 20, 2011 |
| Last Updated: | June 12, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Carboplatin Paclitaxel Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 19, 2013