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OpenTrials
Completed

NCT Number: NCT00065533

Pemetrexed as First Line Chemotherapy for Advanced Breast Cancer

The purposes of this study are to determine the safety of pemetrexed and any side effects that might be associated with it, whether pemetrexed can help patients with breast cancer and how much pemetrexed should be given to patients.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site 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 hrs, EST), or speak with your personal physician., Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be at least 18 years of old.
  • Have been diagnosed with breast cancer
  • At least one year disease-free interval after initial treatment.
  • Have pre-study laboratory tests that are within the requirements of this study.
  • Be able to visit the doctor's office weekly during the treatment period.

Exclusion criteria

  • To be pregnant or breastfeeding.
  • To be currently taking aspirin or aspirin- like medicine and unable to stop for a few days during each cycle of therapy.
  • To have received prior chemotherapy for the treatment of metastatic cancer. Patients may have received prior hormonal treatment.
  • To have another illness that your doctor thinks would make you unable to participate.
  • To be unable or not willing to take folic acid and vitamin B12.

Treatment and study plan

Pemetrexed

Drug

Primary outcomes

  1. To assess tumor response.

Secondary outcomes

  1. To evaluate the toxicity profile of two doses of pemetrexed in breast cancer patients.

  2. To assess the following time-to-event efficacy variables: time to response, duration of response, duration of stable disease, time to documented progressive disease, time to treatment failure, progression-free survival, and overall survival.

  3. To identify the relationships, if any, that may exist between various molecular markers and pemetrexed efficacy and toxicity.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Study of Two Doses of ALIMTA (Pemetrexed) as First Line Chemotherapy for Advanced Breast Cancer

Important dates

Study start
2003
Study completion
2005
First posted
Jul 29, 2003
Registry last updated
Jun 22, 2007

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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