Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

NCT00072865 | Completed Phase 2

• 2 other identifiers: 7771H3E-MW-JMGJ
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.

Conditions

Breast Cancer; Neoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

• antitumor activity

Secondary Outcomes (1)

• duration of response;time to progressive disease;time to treatment failure

Interventions

Pemetrexed DRUG

Carboplatin DRUG

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
• No prior chemotherapy for locally advanced or metastatic breast disease.
• Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
• Adequate bone marrow, liver and kidney function
• RECIST criteria for disease status

You may not qualify if:

• Prior treatment with pemetrexed
• Pregnant or breast feeding
• Brain Metastasis
• unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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

Moscow, Russia, Russia

Location

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

Saint Petersburg, Russia, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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; Coordination Complexes; Organic Chemicals

Study Officials

• 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 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: November 12, 2003
• First Posted: November 13, 2003
• Study Start: June 1, 2003
• Study Completion: September 1, 2005
• Last Updated: January 26, 2007

Record last verified: 2007-01

Locations

RU (2)