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

NCT01407562 | Terminated Phase 1

• 4 other identifiers: Pro0220110062P30CA072720NCI-2011-02448051101
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle

  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

  4 years, 6 months

Secondary Outcomes (1)

• Determine the drug-drug interactions with paclitaxel, carboplatin, and pazopanib

  4 years, 3 months

Study Arms (1)

Pazopanib with paclitaxel and carboplatin

EXPERIMENTAL

Drug: Pazopanib; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Pazopanib DRUG

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

Pazopanib with paclitaxel and carboplatin

Paclitaxel DRUG

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

Pazopanib with paclitaxel and carboplatin

Carboplatin DRUG

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

Pazopanib with paclitaxel and carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator
• GlaxoSmithKline: collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Interventions

pazopanib; Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Nancy Chan, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: August 2, 2011
• Study Start: September 17, 2010
• Primary Completion: March 29, 2016
• Study Completion: March 29, 2016
• Last Updated: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)