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

Tracking Information

First Received Date ^ICMJE

March 17, 2004

Last Updated Date

November 5, 2007

Start Date ^ICMJE

February 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00079872 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The secondary objectives of the study are as follows:
to assess the following time to event efficacy endpoints for patients in both treatment arms:
overall survival
progression free survival
duration of response
to characterize the quantitative and qualitative toxicities of both treatment arms in this patient population

Original Secondary Outcome Measures ^ICMJE

The secondary objectives of the study are as follows:
-to assess the following time to event efficacy endpoints for patients in both treatment arms:
- overall survival
- progression free survival
- duration of response
- to characterize the quantitative and qualitative toxicities of both treatment arms in this patient population

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

Drug: Pemetrexed

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

May 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia, Germany, Greece, Netherlands, Spain

Administrative Information

NCT ID ^ICMJE

NCT00079872

Responsible Party

Study ID Numbers ^ICMJE

2929, H3E-MC-JMAZ

Study Sponsor ^ICMJE

Eli Lilly and Company

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

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)

Eli Lilly and Company

Information Provided By

Eli Lilly and Company

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP