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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-17

Study Completion Date

2016-03-29

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Unspecified Adult Solid Tumor - Protocol Specific Breast Cancer - Female

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pazopanib with paclitaxel and carboplatin

Group Type EXPERIMENTAL

Pazopanib

Intervention Type DRUG

Starting dose is 400 given on Days 2-5, 9-12, and 16-26 of each 28 day cycle

Paclitaxel

Intervention Type DRUG

Starting dose is 60 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle

Carboplatin

Intervention Type DRUG

Starting dose of carboplatin that corresponds to an AUC of 2, IV on days 1, 8, and 15 of each 28 day cycle

Interventions

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Pazopanib

Starting dose is 400 given on Days 2-5, 9-12, and 16-26 of each 28 day cycle

Intervention Type DRUG

Paclitaxel

Starting dose is 60 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No