Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

NCT00106002 | Completed Phase 2 Results DMC

• 2 other identifiers: 9028H3E-US-S045
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.

Conditions

Breast Cancer; Breast Neoplasms, Male; Carcinoma, Ductal

Outcome Measures

Primary Outcomes (1)

• Overall Tumor Response

  Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

  every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

Secondary Outcomes (4)

• Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)

  every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up

• Duration of Tumor Response

  every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

• Progression-Free Survival Time

  every 3 cycles (approximately 6-7 weeks) or until patient has disease progression

• Overall Survival Time

  every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up

Study Arms (1)

A

EXPERIMENTAL

Drug: pemetrexed

Interventions

pemetrexed DRUG

600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression

Also known as: LY231514, Alimta

A

Eligibility Criteria

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

You may qualify if:

• Must have been diagnosed with either advanced or metastatic breast cancer.
• Chemotherapy has not been given for advanced or metastatic breast cancer.
• The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.
• Able to carry out work of a light nature (for example, light housework, office work).
• Must be at least 18 years old.

You may not qualify if:

• Have received prior bone marrow or peripheral stem cell transplantation.
• Have received prior chemotherapy for metastatic breast cancer.
• Are currently pregnant or breast-feeding.
• Have an active infection that your doctor decides will affect your safety.
• Are unable to take folic acid or vitamin B12.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this 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.

Dallas, Texas, 75204, United States

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male; Carcinoma, Ductal

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

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

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

1-800-545-5979

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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: March 18, 2005
• First Posted: March 21, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 1, 2009
• Results First Posted: June 1, 2009

Record last verified: 2009-04

Locations

US (1)