Phase III Randomized Study of Fluorouracil and Leucovorin Calcium With or Without Irinotecan Following Curative Resection in Patients With Stage III Colon Cancer
Last Modified: 6/18/2009 First Published: 5/1/1999
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information
Alternate Title
Combination Chemotherapy in Treating Patients With Stage III Colon
Cancer
Basic Trial Information
| Phase | Type | Status | Age | Protocol IDs |
|---|
| Phase III | Treatment | Completed | 18 and over | CLB-89803
CAN-NCIC-CO15, E-89803, NCCTG-C89803, SWOG-C89803, NCT00003835, C89803, CO15 |
Objectives
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 population.
Entry Criteria Disease Characteristics:
Histologically proven stage III (Tx, N1-2, M0) adenocarcinoma of the colon
Gross inferior (caudal) margin of primary tumor must be above the peritoneal
reflection
Completely resected with negative radial resecting margins
No distant metastatic disease
Prior/Concurrent Therapy:
Biologic therapy:
Not specified
Chemotherapy:
No prior chemotherapy for colon cancer
No other concurrent chemotherapy
Endocrine therapy:
No concurrent hormone therapy except:
Steroids for adrenal failure
Hormones for nondisease related conditions (e.g., diabetes)
Intermittent dexamethasone as an antiemetic
Radiotherapy:
No prior radiotherapy for colon cancer
Surgery:
See Disease Characteristics
Patient Characteristics:
Age:
18 and over
Performance status:
Zubrod 0-2
Life expectancy:
Not specified
Hematopoietic:
Granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hepatic:
Bilirubin no greater than upper limit of normal (ULN)
Renal:
Creatinine no greater than 1.5 times ULN
Other:
No other prior or concurrent malignancy within the past 5 years except
adequately treated basal cell or squamous cell skin cancer or carcinoma in
situ of the cervix
Not pregnant or nursing
Fertile patients must use effective contraception
Expected Enrollment
A total of 1260 patients will be accrued for this study within 3 years. 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 thereafter.
Published ResultsBertagnolli MM, Niedzwiecki D, Compton CC, et al.: Microsatellite instability predicts improved response to adjuvant therapy with irinotecan, fluorouracil, and leucovorin in stage III colon cancer: Cancer and Leukemia Group B Protocol 89803. J Clin Oncol 27 (11): 1814-21, 2009.[PUBMED Abstract] Bertagnolli MM, Warren RS, Niedzwiecki D, et al.: p27Kip1 in stage III colon cancer: implications for outcome following adjuvant chemotherapy in cancer and leukemia group B protocol 89803. Clin Cancer Res 15 (6): 2116-22, 2009.[PUBMED Abstract] Fuchs C, Ogino S, Meyerhardt JA, et al.: KRAS mutation, cancer recurrence, and patient survival in stage III colon cancer: findings from CALGB 89803. [Abstract] J Clin Oncol 27 (Suppl 15): A-4037, 2009. Chan JA, Meyerhardt JA, Niedzwiecki D, et al.: Association of family history with cancer recurrence and survival among patients with stage III colon cancer. JAMA 299 (21): 2515-23, 2008.[PUBMED Abstract] Jackson NA, Fuchs CS, Niedzwiecki D, et al.: The impact of smoking on cancer recurrence and survival in patients with stage III colon cancer: findings from intergroup trial CALGB 89803. [Abstract] J Clin Oncol 26 (Suppl 15): A-4039, 2008. Meyerhardt JA, Niedzwiecki D, Hollis D, et al.: Impact of body mass index and weight change after treatment on cancer recurrence and survival in patients with stage III colon cancer: findings from Cancer and Leukemia Group B 89803. J Clin Oncol 26 (25): 4109-15, 2008.[PUBMED Abstract] Meyerhardt JA, Niedzwiecki D, Hollis D, et al.: The impact of dietary patterns on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. [Abstract] J Clin Oncol 25 (Suppl 18): A-4019, 2007. Meyerhardt JA, Niedzwiecki D, Hollis D, et al.: Association of dietary patterns with cancer recurrence and survival in patients with stage III colon cancer. JAMA 298 (7): 754-64, 2007.[PUBMED Abstract] Saltz LB, Niedzwiecki D, Hollis D, et al.: Irinotecan fluorouracil plus leucovorin is not superior to fluorouracil plus leucovorin alone as adjuvant treatment for stage III colon cancer: results of CALGB 89803. J Clin Oncol 25 (23): 3456-61, 2007.[PUBMED Abstract] Meyerhardt JA, Heseltine D, Niedzwiecki D, et al.: Impact of physical activity on cancer recurrence and survival in patients with stage III colon cancer: findings from CALGB 89803. J Clin Oncol 24 (22): 3535-41, 2006.[PUBMED Abstract] Fuchs C, Meyerhardt JA, Heseltine DL, et al.: Influence of regular aspirin use on survival for patients with stage III colon cancer: findings from Intergroup trial CALGB 89803. [Abstract] J Clin Oncol 23 (Suppl 16): A-3530, 253s, 2005. Meyerhardt JA, Heseltine D, Niedzwiecki D, et al.: The impact of physical activity on patients with stage III colon cancer: findings from Intergroup trial CALGB 89803. [Abstract] J Clin Oncol 23 (Suppl 16): A-3534, 254s, 2005. Saltz LB, Niedzwiecki D, Hollis D, et al.: Irinotecan plus fluorouracil/leucovorin (IFL) versus fluorouracil/leucovorin alone (FL) in stage III colon cancer (intergroup trial CALGB C89803). [Abstract] J Clin Oncol 22 (Suppl 14): A-3500, 245s, 2004.
Trial Contact Information
Trial Lead Organizations Cancer and Leukemia Group B  | | | | Leonard Saltz, MD, Protocol chair | | | Ph: 212-639-2501; 800-525-2225 |
| |
North Central Cancer Treatment Group | | | | Richard Goldberg, MD, Protocol chair(Contact information may not be current) | | | |
NCIC-Clinical Trials Group | | | | David Klaassen, MD, Protocol chair(Contact information may not be current) | | | Ph: 604-877-6000; 800-663-3333 |
| |
Southwest Oncology Group | | | | Alexander Hantel, MD, Protocol chair | | | |
Eastern Cooperative Oncology Group | | | | James Thomas, MD, PhD, Protocol chair | | | |
| Registry Information | | | Official Title | | 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 | | | Trial Start Date | | 1999-04-15 | | | Registered in ClinicalTrials.gov | | NCT00003835 1 | | | Date Submitted to PDQ | | 1999-03-26 | | | Information Last Verified | | 2009-06-18 | | | NCI Grant/Contract Number | | U10-CA31946 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
Table of Links
| 1 | http://clinicaltrials.gov/ct/show/NCT00003835 |
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