Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.

Completed · Phase 3 · Has a placebo group

Conditions studied: Colorectal Neoplasms

In brief

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 study it compares FOLFIRI \[a chemotherapy regime that combines bolus irinotecan and leucovorin \[LV\] with infusional 5-fluorouracil (5-FU)\] + bevacizumab and mlFL + bevacizumab. Measures of efficacy and safety will be reported.

Key facts

Study ID

NCT00101686

Run by

Pfizer

People needed

547

Starts

2003-02-01

Expected to finish

2008-10-01

Last updated by the study team

2010-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmngham, Alabama, United States
• Pfizer Investigational Site — Mobile, Alabama, United States
• Pfizer Investigational Site — Flagstaff, Arizona, United States
• Pfizer Investigational Site — Sedona, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Hot Spring, Arkansas, United States
• Pfizer Investigational Site — Springdale, Arkansas, United States
• Pfizer Investigational Site — Arroyo Grande, California, United States
• Pfizer Investigational Site — Fountian Valley, California, United States
• Pfizer Investigational Site — Fresno, California, United States
• Pfizer Investigational Site — Los Gatos, California, United States
• Pfizer Investigational Site — Mission Hills, California, United States
• Pfizer Investigational Site — Modesto, California, United States
• Pfizer Investigational Site — Orange, California, United States
• Pfizer Investigational Site — Oxnard, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Jose, California, United States
• Pfizer Investigational Site — Boulder, Colorado, United States
• Pfizer Investigational Site — Norwalk, Connecticut, United States
• Pfizer Investigational Site — Stamford, Connecticut, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Altamonte Springs, Florida, United States
• Pfizer Investigational Site — Hollywood, Florida, United States
• Pfizer Investigational Site — Birmgingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.