Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Genzyme

Status and phase: Completed; Phase 1

Conditions: Colorectal; Metastatic; Adenocarcinoma

Treatments: Drug: Leucovorin; Drug: ZD6474 (vandetanib) 100mg; Drug: ZD6474 (vandetanib) 300mg; Drug: 5-Fluorouracil; Drug: Irinotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00507091

D4200C00038

Details and patient eligibility

About

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed metastatic colorectal adenocarcinoma
2. Not amenable to surgery or radiation therapy
3. Eligible for first or second line chemotherapy

Exclusion criteria

1. Brain metastases or spinal compression
2. Last prior chemotherapy discontinued within 4 weeks before start
3. Last dose radiotherapy within 4 weeks of start

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

ZD6474 (vandetanib) 100mg

Experimental group

Treatment:

Drug: Irinotecan

Drug: Leucovorin

Drug: 5-Fluorouracil

Drug: ZD6474 (vandetanib) 100mg

ZD6474 (vandetanib) 300mg

Experimental group

Treatment:

Drug: Irinotecan

Drug: Leucovorin

Drug: 5-Fluorouracil

Drug: ZD6474 (vandetanib) 300mg