Study of the GARFT Inhibitor AG2037 in Patients With Metastatic Colorectal Cancer Who Failed Treatment
NCT ID: NCT00078468
Last Updated: 2006-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2003-12-31
2004-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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PELITREXOL/AG-2037
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Poway, California, United States
Pfizer Investigational Site
Washington D.C., District of Columbia, United States
Pfizer Investigational Site
Tampa, Florida, United States
Pfizer Investigational Site
New York, New York, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A4371004
Identifier Type: -
Identifier Source: org_study_id
NCT00085592
Identifier Type: -
Identifier Source: nct_alias