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Completed

NCT Number: NCT00106002

Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Pemetrexed

Drug

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

Other names: LY231514, Alimta

Primary outcomes

  1. Overall Tumor Response

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

    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.

Secondary outcomes

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

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

    Participants rated for toxicity prior to each cycle using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Grades range from 0 (no AE or within normal limits) to 5 (death related to AE).

  2. Duration of Tumor Response

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

    Defined as time from first observation of complete response or partial response to the first observation of progressive disease or death due to any cause.

  3. Progression-Free Survival Time

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

    Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause.

  4. Overall Survival Time

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

    Defined as the time from date of first dose to time of death due to any cause.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Mar 21, 2005
Registry last updated
Jun 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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