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Pemetrexed-Carboplatin and Gemcitabine-Vinorelbine in Advanced Breast Cancer

NCT00325234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2011-05-20

Study results available
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Summary

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

Conditions

Interventions

DRUG

Pemetrexed

600 mg/m\^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.

DRUG

Carboplatin

AUC 5 mg\*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity.

DRUG

Gemcitabine

1200 mg/m\^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

DRUG

Vinorelbine

30 mg/m\^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon- Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2010-04-30
Completion
2010-08-31

Countries

  • Germany
  • Italy
  • South Africa
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00325234 on ClinicalTrials.gov