Irinotecan Discontinuation and Reintroduction for Advanced Colorectal Cancer

Phase 2TerminatedNCT00320320

Gachon University Gil Medical Center72 enrolled

Overview

The purpose of this study is to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

For medically-fit patients with advanced colorectal cancer, the current standard approach is chemotherapy with FOLFIRI or FOLFOX. Although a strategy of using sequential 5-FU, irinotecan and oxaliplatin has been thought to maximize overall survival in such patients, significant toxicity remains a problem. It has been suggested feasible that chemotherapy can be discontinued after 2-3 months and restart same treatment on progression in patients with chemosensitive colorectal cancer. Thus we designed this pilot phase II study to evaluate the feasibility and efficacy of first-line FOLFIRI discontinuation after initial 8 cycles and reintroduction after progression.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Neoplasms Metastases

Interventions

IrinotecanDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven adenocarcinoma of colon and rectum * No prior chemotherapy or only adjuvant chemotherapy and/or radiotherapy * Advanced, metastatic or recurrent not amenable to curative local therapy * Measurable lesion(s) * ECOG performance status 0 to 2 * Normal marrow, hepatic and renal function * Provision of written informed consent Exclusion Criteria: * Active infection and/or severe comorbidity * Known history of anaphylaxis of any origin

Locations (1)

Gachon University Gil Medical Center

Incheon, South Korea

Outcomes

Primary Outcomes

Response rate after FOLFIRI reintroduction

Secondary Outcomes

Progression-free survival

Overall survival

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.