Know Cancer

or
forgot password

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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company

Authority:

United States: Food and Drug Administration

Study ID:

2929

NCT ID:

NCT00079872

Start Date:

February 2004

Completion Date:

May 2006

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

Name

Location