A Study of Biweekly Pemetrexed and Gemcitabine in Patients With Metastatic Breast Cancer

NCT00191347 | Completed Phase 2

• 2 other identifiers: 9305H3E-CA-S050
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine the efficacy of the biweekly pemetrexed/gemcitabine regimen when given to patients with metastatic breast cancer. Each agent has well demonstrated antitumor activity in patients with locally advanced or metastatic breast cancer. In addition, in the phase I combination trial of the two agents, a durable tumor response was seen in one out of three heavily pretreated breast cancer patients (Adjei et al. 2000). Therefore, it is reasonable to expect that the combination of pemetrexed and gemcitabine administered may be associated with considerably more anti-tumor activity than either agent alone. If such activity is seen in this study, randomized studies comparing this combination with other active agents or combinations of active agents will be considered.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the objective tumor response rate for pemetrexed plus gemcitabine administered every 14 days, in patients with MBC who have received up to one prior chemotherapy for metastatic disease(not including prior adjuvant chemotherapy)

Secondary Outcomes (1)

• To measure time-to-event efficacy variables including: time to objective tumor response for responding patients, duration of response for responding pts, time to treatment failure, time to progressive disease, progression free survival, overall survival

Interventions

pemetrexed DRUG

gemcitabine DRUG

Eligibility Criteria

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

You may qualify if:

• Have a performance status of 0 to 2 on the ECOG performance status schedule.
• Patients may have had up to one prior systemic chemotherapy for metastatic disease is allowed. Prior adjuvant therapy is allowed if it has been more than one year since the end of therapy.
• Patients must have measurable disease as defined by RECIST criteria (Therasse et al. 2000):
• Have adequate organ function including the following

You may not qualify if:

• \. Have serious concomitant systemic disorders (eg, active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for thsi trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Ottawa, Ontario, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Pemetrexed; Gemcitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours,EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2004
• Study Completion: November 1, 2005
• Last Updated: January 26, 2007

Record last verified: 2007-01

Locations

CA (1)