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Completed

NCT Number: NCT00079872

Pemetrexed Plus a Comparator Versus a Combination of 2 Comparators in First-Line Treatment of Colorectal Cancer

In this study, patients will receive either pemetrexed plus irinotecan or 5-fluorouracil (5-FU), leucovorin, and irinotecan.

The purposes of this study are to determine:

* How pemetrexed plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms of efficacy. * The safety of pemetrexed plus irinotecan and any side effects that might be associated with it as compared with 5-FU, leucovorin, and irinotecan. * Whether pemetrexed can help patients with colorectal cancer.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal 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) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, NSW, QLD, South Australia, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The patient must have:

  • Histologic or cytologic diagnosis of adenocarcinoma of the colon or rectum.
  • Performance status of 0 to 2 on the ECOG Performance Status Scale.
  • Standard postoperative adjuvant radiation therapy for rectal cancer is allowed.
  • Locally advanced or metastatic disease.
  • Must be 18 years of age.

Exclusion criteria

The patient must not have:

  • Received prior chemotherapy for advanced disease. Prior adjuvant therapy, including 5-FU, is allowed if it has been more than 12 months since the last treatment.
  • Received prior treatment with irinotecan in the adjuvant setting.
  • Are unable to take vitamin B12 or folic acid.
  • Are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs, or COX-2 inhibitors for a 5-day period.
  • Have a second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.

Treatment and study plan

Pemetrexed

Drug

Primary outcomes

  1. The primary objective is to compare the antitumor activity of pemetrexed plus a comparator with that of leucovorin modulated 5 FU plus a comparator as measured by tumor response rate for patients with locally advanced or metastatic colorectal cancer

Secondary outcomes

  1. The secondary objectives of the study are as follows:

  2. to assess the following time to event efficacy endpoints for patients in both treatment arms:

  3. overall survival

  4. progression free survival

  5. duration of response

  6. to characterize the quantitative and qualitative toxicities of both treatment arms in this patient population

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized Phase 2 Trial of ALIMTA Plus a Comparator Versus Leucovorin Modulated Fluorouracil Plus a Comparator in First Line Treatment of Locally Advanced or Metastatic Colorectal Cancer

Important dates

Study start
2004
Study completion
2006
First posted
Mar 19, 2004
Registry last updated
Nov 6, 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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