Status:
COMPLETED
Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.
Lead Sponsor:
Pfizer
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of stud...
Eligibility Criteria
Inclusion
- Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (Stage IV distant disease)
- Present or past histological documentation of adenocarcinoma of the colon or rectum. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:
- An interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease.
- The primary cancer was a Duke's A or B1.
- Physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases.
Exclusion
- Patients who received any prior systemic anticancer therapy for metastatic colorectal cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents).
- Patients cannot have concurrent malignancies at study entry.
- Exceptions: Patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). Patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
547 Patients enrolled
Trial Details
Trial ID
NCT00101686
Start Date
February 1 2003
End Date
October 1 2008
Last Update
January 12 2010
Active Locations (175)
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1
Pfizer Investigational Site
Birmgingham, Alabama, United States, 35205
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
3
Pfizer Investigational Site
Birmngham, Alabama, United States, 35211
4
Pfizer Investigational Site
Mobile, Alabama, United States, 36608