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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Colorectal Neoplasms

Treatments: Drug: Infusional 5-FU/LV with Irinotecan; Drug: FOLFIRI + bevacizumab; Drug: Oral Capecitabine with Irinotecan; Drug: Modified Bolus 5-FU/LV with Irinotecan; Drug: miFL + bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00101686

A5961021

CPTAIV-0020-411

Details and patient eligibility

About

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.

Enrollment: 547 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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547 participants in 5 patient groups

Modified Bolus 5-FU/LV with Irinotecan

Experimental group

Treatment:

Drug: Modified Bolus 5-FU/LV with Irinotecan

FOLFIRI + bevacizumab

Experimental group

Treatment:

Drug: FOLFIRI + bevacizumab

miFL + bevacizumab

Experimental group

Treatment:

Drug: miFL + bevacizumab

Infusional 5-FU/LV with Irinotecan

Experimental group

Treatment:

Drug: Infusional 5-FU/LV with Irinotecan

Oral Capecitabine with Irinotecan

Other group

Treatment:

Drug: Oral Capecitabine with Irinotecan