NCT00894504

Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast Cancer

A Phase II Trial of Panitumumab, Gemcitabine, and Carboplatin in Triple-Negative Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this Phase II trial, the investigators will evaluate the combination of gemcitabine, carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be examined for the presence of various markers, including K-ras and PI3K-activating mutations, EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a patient subset that is particularly responsive to treatment with a panitumumab-containing combination.

Detailed description

All patients will receive a pre-emptive skin care regimen during panitumumab therapy to reduce skin toxicity. Treatment cycles will be repeated every 14 days (2 weeks). During each treatment, panitumumab will be administered first, then carboplatin, then gemcitabine. All drugs will be administered according to standard guidelines. Patients will be re-evaluated for response after completion of 3 cycles (6 weeks) of treatment. Patients with objective response or stable disease will continue treatment. Subsequent re-evaluations will occur every 6 weeks. Patients will continue treatment with all three drugs until tumor progression, or until unacceptable toxicity occurs. If patients experience toxicity caused by gemcitabine/carboplatin and are continuing to benefit from treatment, panitumumab can be continued as a single agent (at the same dose and schedule), at the discretion of the investigator, until disease progression occurs.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Panitumumab	6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
DRUG	Carboplatin	AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
DRUG	Gemcitabine	1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)

Timeline

• Start date: 2010-02-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2009-05-07
• Last updated: 2015-05-15
• Results posted: 2014-12-15

Locations

17 sites across 1 country: United States