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Irinotecan and 5-Fluorouracil/Leucovorin for Patients With Colorectal Carcinoma and Other Refractory Tumors


Phase 2
N/A
24 Years
Not Enrolling
Both
Carcinoma of Unknown Primary, Colorectal Cancer, Unspecified Adult Solid Tumor, Protocol Specific, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

Irinotecan and 5-Fluorouracil/Leucovorin for Patients With Colorectal Carcinoma and Other Refractory Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Wayne Lee Furman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067216

NCT ID:

NCT00004005

Start Date:

September 1998

Completion Date:

October 2005

Related Keywords:

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

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794