Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors

Rutgers The State University of New Jersey

Status and phase: Terminated; Phase 1

Conditions: Unspecified Adult Solid Tumor - Protocol Specific; Breast Cancer - Female

Treatments: Drug: Paclitaxel; Drug: Carboplatin; Drug: Pazopanib

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01407562

P30CA072720 (U.S. NIH Grant/Contract)

051101

NCI-2011-02448 (Other Identifier)

Pro0220110062

Details and patient eligibility

About

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.

Full 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).

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

Pazopanib with paclitaxel and carboplatin

Experimental group

Treatment:

Drug: Pazopanib

Drug: Carboplatin

Drug: Paclitaxel