Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
A Randomized Phase III Trial of Three Different Regimens of CPT-11 Plus 5-Fluorouracil and Leucovorin Compared to 5-Fluorouracil and Leucovorin in Patients With Advanced Adenocarcinoma of the Colon and Rectum
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which regimen of combination chemotherapy is most effective in treating advanced colorectal cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of various combination chemotherapy regimens in treating patients who have advanced, recurrent, or metastatic colorectal cancer that cannot be treated with surgery or radiation therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- irinotecan + leucovorin + fluorouracil
- description
- Patients receive irinotecan IV over 90 minutes followed by leucovorin calcium IV over 15 minutes and fluorouracil IV once a week for 4 weeks followed by 2 weeks of rest. Courses repeat every 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
- interventionNames
- Drug: irinotecan
- Drug: fluorouracil
- Drug: leucovorin calcium
- type
- EXPERIMENTAL
- label
- oxaliplatin + leucovorin + fluorouracil
- description
- Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV over 2 hours plus fluorouracil IV over 22 hours on days 1 and 2. Courses repeat every 2 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before treatment, during treatment (arm specific), and after completion of treatment. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma not curable by surgery or radiotherapy
* Histological or cytological requirement waived in patients who developed radiological or clinical evidence of metastatic cancer after a prior surgical resection unless:
* More than 5 years has elapsed since primary surgery OR
* Primary cancer was stage I or II
* Site of primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel
* Measurable or evaluable disease
* No CNS metastases or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 12 weeks
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9.0 g/dL (transfusion allowed)
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* AST no greater than 5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No uncontrolled hypertension
* No unstable angina
* No symptomatic congestive heart failure
* No myocardial infarction within the past 6 months
* No serious uncontrolled arrhythmia
* No New York Heart Association class III or IV cardiac disease
Pulmonary:
* No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
* No pleural effusion or ascites that cause respiratory compromise (grade 2 or worse dyspnea)
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active or uncontrolled infection
* No symptomatic sensory peripheral neuropathy
* No known allergy to platinum compounds
* No history of gastrointestinal bleeding unless it is determined to be acceptable by the enrolling physician
* No other prior or concurrent malignancy within the past 3 years except nonmelanoma skin cancer, carcinoma in situ of the uterine cervix, or other resected malignant tumor with less than a 10% probability of tumor relapse within 3 years of diagnosis
* No medical or psychiatric conditions that would preclude study
* No colonic or small bowel disorders with uncontrolled symptoms of more than 3 loose stools per day
* Colostomy or ileostomy allowed at investigator's discretion
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior adjuvant immunotherapy for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease
* No concurrent sargramostim (GM-CSF)
Chemotherapy:
* No prior chemotherapy for advanced colorectal cancer
* No prior standard adjuvant chemotherapy for rectal cancer
* Prior adjuvant fluorouracil for resected stage II-IV disease allowed if adjuvant therapy concluded at least 1 year before documentation of recurrent disease
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior major radiotherapy (e.g., chest or bone palliative radiotherapy)
* No prior radiotherapy to more than 15% of bone marrow
* No prior standard adjuvant radiotherapy for rectal cancer
Surgery:
* See Disease Characteristics
* At least 4 weeks since prior major surgery (e.g., laparotomy) (2 weeks for minor surgery) and recovered
* Insertion of a vascular access device not considered major or minor surgery
Other:
* No other concurrent investigational agentsReferences
Publications (28)
- BACKGROUNDFranko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12. PMID 22162570
- BACKGROUNDAn MW, Mandrekar SJ, Branda ME, Hillman SL, Adjei AA, Pitot HC, Goldberg RM, Sargent DJ. Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clin Cancer Res. 2011 Oct 15;17(20):6592-9. doi: 10.1158/1078-0432.CCR-11-0822. Epub 2011 Aug 31. PMID 21880789
- BACKGROUNDCampbell ME, Mandrekar SJ, Hillman SL, et al.: What is the added value of actual tumor measurements (TM) in predicting overall survival (OS)? The North Central Cancer Treatment Group (NCCTG) findings. [Abstract] J Clin Oncol 26 (Suppl 15): A-6520, 2008.
- BACKGROUNDGrothey A, Hedrick EE, Mass RD, Sarkar S, Suzuki S, Ramanathan RK, Hurwitz HI, Goldberg RM, Sargent DJ. Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. J Clin Oncol. 2008 Jan 10;26(2):183-9. doi: 10.1200/JCO.2007.13.8099. PMID 18182660
- BACKGROUNDGrothey A, Hedrick EE, Mass RD, et al.: Response rate using conventional criteria is a poor surrogate for clinical benefit on progression-free (PFS) and overall survival (OS) in metastatic colorectal cancer (mCRC): a comparative analysis of N9741 and AVF2107. [Abstract] J Clin Oncol 24 (Suppl 18): A-3516, 2006.
- BACKGROUNDGoldberg R. Oxaliplatin in colorectal cancer: current studies. Oncology (Williston Park). 2000 Dec;14(12 Suppl 11):42-7. PMID 11204663
- RESULTHeun JM, Grothey A, Branda ME, Goldberg RM, Sargent DJ. Tumor status at 12 weeks predicts survival in advanced colorectal cancer: findings from NCCTG N9741. Oncologist. 2011;16(6):859-67. doi: 10.1634/theoncologist.2011-0064. Epub 2011 May 31.