Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00078468
Recruitment Status : Completed
First Posted : March 2, 2004
Last Update Posted : November 9, 2006
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Brief Summary:
To determine the response rate in patients with metastatic colorectal cancer who failed treatment with a 5-Fluorouracil/Leucovorin regimen and up to one other chemotherapeutic regimen (not including adjuvant chemotherapy).

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: PELITREXOL/AG-2037 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open-Label Multicenter Study Of The Garft Inhibitor AG2037 In Patients With Metastatic Colorectal Cancer Who Failed Treatment With A 5-Fluorouracil/Leucovorin Regimen.
Study Start Date : December 2003
Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To determine the overall objective response rate (complete and partial responses) of AG-2037 in patients with metastatic colorectal cancer who failed treatment with 5FU/LV regimen and up to one other chemotherapeutic regimen.

Secondary Outcome Measures :
  1. To estimate time to progression (TTP).
  2. To evaluate the overall survival (1-year) of patients treated with AG-2037.
  3. To assess changes in patient reported outcomes using health-related quality of life questionnaires.
  4. To evaluate the safety of AG-2037.
  5. To evalutate the PK and PD of AG-2037.
  6. To correlate the various genetic markers of MTAP, folate and purine metabolism with clinical response.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum
  • Stage IV or recurrent disease
  • Measurable disease
  • Disease progression or recurrence during or after completion of prior first-line chemotherapy with fluorouracil and leucovorin calcium (5-FU/LV)
  • Prior irinotecan or oxaliplatin as part of the 5-FU/LV regimen or as subsequent therapy allowed
  • Only 2 prior regimens for metastatic disease allowed
  • One additional regimen as adjuvant therapy allowed provided patient remained disease-free for > 6 months after completion of therapy*
  • Newer, targeted investigational agents (e.g., cetuximab or bevacizumab) are not

counted as a chemotherapeutic regimen unless used in combination with a cytotoxic regimen NOTE: *If evidence of failure occurred within < 6 months after completion of adjuvant therapy, patients may have received only 1 additional regimen for metastatic disease

  • No active brain metastases (requiring treatment or progressing)

Exclusion Criteria:

  • History of blood transfusion within 14 days
  • Need of concurrent Administration of allopurinol
  • History of Radiotherapy or Chemotherapy within 4 weeks
  • Any psychological or sociological condition, addidtive disorder or family problems that might preclude compliance with the protocol
  • Any unstable or severe intercurrent medical condition that in the opinion of th einvestigator might interfere with achievement of study objectives
  • Receipt of an investigational agent within 28 days prior to first day of dosing with AG-2037
  • Pregnant or breast feeding
  • Previous treatment with GARFT inhibitors
  • History of a malignancy (other than colorectal cancer) excpet those treated with curative intent for skin cancer (other than melanoma) or in situ breast or cervical cancer or those treated with curative intent for any other cancer with no evidence of disease for 5 years
  • Active brain metastases (requiring treatment or progression)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00078468

United States, California
Pfizer Investigational Site
Poway, California, United States, 92064
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33612
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10021
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information: Identifier: NCT00078468     History of Changes
Obsolete Identifiers: NCT00085592
Other Study ID Numbers: A4371004
First Posted: March 2, 2004    Key Record Dates
Last Update Posted: November 9, 2006
Last Verified: August 2006

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases