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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

Primary Purpose

Carcinoma of Unknown Primary, Colorectal Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fluorouracil
irinotecan hydrochloride
leucovorin calcium
conventional surgery
radiation therapy
Sponsored by
St. Jude Children's Research Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma of Unknown Primary focused on measuring 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

Eligibility Criteria

undefined - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Jude Children's Research Hospital

Outcomes

Primary Outcome Measures

Response rate
Toxicity
Disease-free survival

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
April 24, 2017
Sponsor
St. Jude Children's Research Hospital
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00004005
Brief Title
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
Official Title
Irinotecan and 5-Fluorouracil/Leucovorin for Patients With Colorectal Carcinoma and Other Refractory Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
September 1998 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Jude Children's Research Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma of Unknown Primary, Colorectal Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Intervention Type
Drug
Intervention Name(s)
leucovorin calcium
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Response rate
Title
Toxicity
Title
Disease-free survival

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Lee Furman, MD
Organizational Affiliation
St. Jude Children's Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.stjude.org
Description
St. Jude Children's Research Hospital

Learn more about this trial

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

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