Pemetrexed-Carboplatin and Gemcitabine-Vinorelbine in Advanced Breast Cancer

Sponsor
Eli Lilly and Company
Study ID
NCT00325234
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pemetrexed — DRUG
    600 mg/m\^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.
  • Carboplatin — DRUG
    AUC 5 mg\*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity.
  • Gemcitabine — DRUG
    1200 mg/m\^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.
  • Vinorelbine — DRUG
    30 mg/m\^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

Study Details

The primary purpose of this study is to help answer the following research questions: * whether the chemotherapy combination therapy Pemetrexed-Carboplatin or Gemcitabine-Vinorelbine can help participants with advanced breast cancer to make the tumor smaller or disappear and for how long * to learn more about the side effects in each chemotherapy combination treatment arm * to assess how participants with advanced breast cancer report health changes while receiving any of the chemotherapy combination arm

Key Dates

Start date
Jun 30, 2006
Status verified
Apr 2011
Primary completion
Apr 30, 2010
Completion
Aug 31, 2010

Study Design

Enrollment
135 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pemetrexed/Carboplatin
    Pemetrexed 600 mg/m\^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC (Area under the plasma drug concentration versus time curve) 5.0 mg\*min/mL. The cycle of treatment was 21 days.
  • Active Comparator: Gemcitabine/Vinorelbine
    Vinorelbine 30 mg/m\^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m\^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.

Primary Outcome Measure

Tumor Response Rate [ Time Frame: Baseline up to 30 days of follow-up after 21 cycles of treatment ]

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