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A Pilot Phase II Trial of Irinotecan Discontinuation and Reintroduction in Patients With Previously Untreated Advanced Colorectal Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Both
Colorectal Neoplasms, Metastases

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Trial Information

A Pilot Phase II Trial of Irinotecan Discontinuation and Reintroduction in Patients With Previously Untreated Advanced Colorectal Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate after FOLFIRI reintroduction

Principal Investigator

Se Hoon Park, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gachon University Gil Medical Center, Incheon, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

GMO-GI-53

NCT ID:

NCT00320320

Start Date:

April 2005

Completion Date:

April 2007

Related Keywords:

  • Colorectal Neoplasms
  • Metastases
  • No prior chemotherapy
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

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