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Irinotecan Followed By Fluorouracil and Leucovorin in Treating Patients With Stage III or Stage IV Colorectal Carcinoma (Cancer), Other Refractory Carcinoma, or Metastatic Adenoma (Cancer) of Unknown Primary Origin

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
St. Jude Children's Research Hospital Identifier:
First received: November 1, 1999
Last updated: April 24, 2017
Last verified: October 2011

RATIONALE: Drugs used in chemotherapy, such as irinotecan, fluorouracil, and leucovorin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with stage III or stage IV colorectal carcinoma (cancer), other refractory carcinoma (cancer), or metastatic adenocarcinoma (cancer) of unknown primary origin.

Condition Intervention Phase
Carcinoma of Unknown Primary
Colorectal Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Procedure: conventional surgery
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Irinotecan and 5-Fluorouracil/Leucovorin for Patients With Colorectal Carcinoma and Other Refractory Tumors

Resource links provided by NLM:

Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Response rate
  • Toxicity
  • Disease-free survival

Enrollment: 12
Study Start Date: September 1998
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:


  • Determine the response rate in patients with stage IV colorectal carcinoma or other carcinomas treated with irinotecan followed by fluorouracil and leucovorin calcium.
  • Determine the disease-free survival of patients with stage III colorectal carcinoma, other refractory carcinomas, or metastatic adenocarcinomas of unknown primary site treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: Patients with stage III colorectal carcinoma (post surgical resection) receive irinotecan IV over 1 hour on days 1-5 and days 8-12. Treatment repeats every 3 weeks for 2 courses. Beginning on week 7, patients receive pelvic irradiation, leucovorin calcium IV over 4 hours, and fluorouracil IV over 5-15 minutes beginning 1 hour into leucovorin calcium infusion on days 1-5. Treatment repeats every 3 weeks for a total of 2 courses. Patients with no evidence of disease may repeat the above 12-week block of chemotherapy without pelvic irradiation up to 4 times over 1 year.

Patients with stage IV colorectal carcinoma, other refractory carcinomas, or metastatic adenocarcinomas of unknown primary site receive the above 12-week block of chemotherapy (irinotecan, fluorouracil, and leucovorin calcium) with pelvic irradiation (if indicated). Pelvic irradiation patients with an unresected primary tumor undergo exploratory surgery 4-5 weeks after completion of radiotherapy, even in the absence of visible tumor regression. Radical resection is attempted to effect local control and control of long term symptoms related to the primary tumor. Patients with complete response (CR) or partial response (PR) after both chemotherapy and surgery repeat the above 12-week block of chemotherapy 3 times over 1 year in the absence of disease progression or unacceptable toxicity. Patients with CR or PR after chemotherapy but no response after surgery receive irinotecan IV over 1 hour on days 1-5 and days 8-12 every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Patients with stable disease (SD) or progressive disease after 2 courses of irinotecan and SD, CR, or PR after surgery receive leucovorin calcium and fluorouracil as above every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 years.


Ages Eligible for Study:   up to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • One of the following diagnoses:

    • Histologically proven previously untreated stage III or stage IV colorectal carcinoma
    • Other carcinomas refractory to standard treatment
    • Metastatic adenocarcinoma of unknown primary site



  • Under 25

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 8 weeks


  • Hemoglobin at least 10.0 g/dL
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Albumin greater than 3.0 g/dL
  • Bilirubin less than 1.5 mg/dL
  • SGOT or SGPT less than 2 times normal


  • Creatinine less than 1.5 mg/dL OR
  • Creatinine clearance greater than 80 mL/min
  • Urinalysis normal


  • Blood glucose normal
  • Electrolytes normal
  • Prior curatively treated childhood cancer allowed
  • Weight greater than 10th percentile for height
  • Not pregnant or nursing
  • Negative pregnancy test


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00004005

United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
Study Chair: Wayne Lee Furman, MD St. Jude Children's Research Hospital
  More Information

Additional Information: Identifier: NCT00004005     History of Changes
Other Study ID Numbers: CDR0000067216
P30CA021765 ( US NIH Grant/Contract Award Number )
Study First Received: November 1, 1999
Last Updated: April 24, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by St. Jude Children's Research Hospital:
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
unspecified childhood solid tumor, protocol specific
unspecified adult solid tumor, protocol specific
adenocarcinoma of unknown primary
newly diagnosed carcinoma of unknown primary
recurrent carcinoma of unknown primary

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic processed this record on May 25, 2017