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Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC# 616348) Plus Luorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection for Patients With Stage III Colon Cancer

Phase 3
18 Years
Not Enrolling
Adenocarcinoma of the Colon, Stage III Colon Cancer

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Trial Information

Phase III Intergroup Trial of Irinotecan (CPT-11) (NSC# 616348) Plus Luorouracil/Leucovorin (5-FU/LV) Versus Fluorouracil/Leucovorin Alone After Curative Resection for Patients With Stage III Colon Cancer


I. Compare the overall and disease free survival of patients with stage III colon cancer
treated with adjuvant fluorouracil and leucovorin calcium with or without irinotecan.

II. Assess prognostic markers and correlate their expression with disease free and overall
survival of these patients.

III. Assess the influence of diet, body mass index, and physical activity on the risk of
cancer recurrence and survival in these patients.

IV. Assess the influence of diet, obesity, and physical activity on the risk of toxicity
associated with adjuvant therapy in these patients.

V. Determine whether pathological features (including tumor grade, tumor mitotic
(proliferation) index, tumor border configuration, and host lymphoid response to tumor; and
lymphatic vessel, venous vessel and perineural invasion) predict outcome in this patient

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to lymph
node involvement (1-3 vs 4 or more), histology (poorly differentiated or undifferentiated vs
well or moderately differentiated), and preoperative serum CEA (less than 5.0 ng/mL vs at
least 5.0 ng/mL vs unknown). Study therapy must begin within 21-56 days after surgery.
Patients are randomized to one of two treatment arms:

ARM I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV beginning 1
hour into leucovorin calcium infusion weekly for 6 weeks. Treatment is repeated every 8
weeks for 4 courses.

ARM II: Patients receive irinotecan IV over 90 minutes, followed by leucovorin calcium IV,
then followed by fluorouracil IV weekly for 4 weeks. Treatment is repeated every 6 weeks for
5 courses.

Patients complete a food questionnaire at the beginning of the third course and then at 6
months after study therapy.

Patients are followed every 3 months for 2 years, every 4 months for 2 years, then annually

PROJECTED ACCRUAL: A total of 1260 patients will be accrued for this study within 3 years.

Inclusion Criteria:

- Patients must have histologically documented adenocarcinoma of the colon; the gross
inferior (caudad) margin of the primary tumor must lie above the peritoneal
reflection; tumor must have been completely resected, including negative radial
resecting margins

- There must be no history of distant metastatic disease at the time of registration

- Pathological evaluation must show Modified Astler-Coller stage C (TxN1-2M0) disease

- No previous or concurrent malignancy is allowed except for adequately treated basal
cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which
the patient has been disease-free for five years

- Zubrod performance status of 0-2

- Non-pregnant and not nursing, as chemotherapy is thought to present substantial risk
to the fetus/infant; men and women of reproductive potential may not participate
unless they have agreed to use an effective contraceptive method while in this study

- Granulocytes >= 1,500/ul

- Platelet count >= 100,000/ul

- Creatinine =< 1.5 x upper limits of normal

- Bilirubin =< upper limit of normal

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to recurrence

Outcome Description:

The Cox proportional hazards model will be used to determine the association between each marker and time to recurrence and survival controlling for other baseline factors such as age, gender, treatment, primary tumor site, degree of differentiation.

Outcome Time Frame:

From time of resection until documented disease progression, assessed up to 6 years

Safety Issue:


Principal Investigator

Leonard Saltz

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

April 1999

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Colon
  • Stage III Colon Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colonic Neoplasms



Cancer and Leukemia Group B Chicago, Illinois  60606