- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004005
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
Irinotecan and 5-Fluorouracil/Leucovorin for Patients With Colorectal Carcinoma and Other Refractory Tumors
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Tennessee
-
Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age:
- Under 25
Performance status:
- ECOG 0-2
Life expectancy:
- At least 8 weeks
Hematopoietic:
- Hemoglobin at least 10.0 g/dL
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Albumin greater than 3.0 g/dL
- Bilirubin less than 1.5 mg/dL
- SGOT or SGPT less than 2 times normal
Renal:
- Creatinine less than 1.5 mg/dL OR
- Creatinine clearance greater than 80 mL/min
- Urinalysis normal
Other:
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Response rate
|
Disease-free survival
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Wayne Lee Furman, MD, St. Jude Children's Research Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- unspecified childhood solid tumor, protocol specific
- unspecified adult solid tumor, protocol specific
- stage IV rectal cancer
- stage IV colon cancer
- stage III colon cancer
- stage III rectal cancer
- newly diagnosed carcinoma of unknown primary
- recurrent carcinoma of unknown primary
- adenocarcinoma of unknown primary
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Neoplastic Processes
- Neoplasm Metastasis
- Neoplasms
- Carcinoma
- Colorectal Neoplasms
- Neoplasms, Unknown Primary
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Protective Agents
- Topoisomerase Inhibitors
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Topoisomerase I Inhibitors
- Antidotes
- Vitamin B Complex
- Fluorouracil
- Leucovorin
- Irinotecan
- Calcium
- Levoleucovorin
Other Study ID Numbers
- CDR0000067216
- P30CA021765 (U.S. NIH Grant/Contract)
- SJCRH-CACO5
- NCI-G99-1554
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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