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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 an

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Trial Conditions
  • Colorectal Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Endocrine therapy:

- Not specified

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 agents

Gender: Both
Steward Physician(s)
  • Henry C. Pitot, MD
  • Roscoe F. Morton, MD, FACP
  • Charles S. Fuchs, MD
  • Brian P. Findlay, MD
  • Ramesh K. Ramanathan, MD
  • Stephen K. Williamson, MD
Facilities
  • Morton Hospital - Completed
Trial Interventions
Drug
  • FOLFOX regimen
  • fluorouracil
  • leucovorin calcium
  • oxaliplatin
Physician Researcher

Investigator Name:

  • Henry C. Pitot, MD
  • Roscoe F. Morton, MD, FACP
  • Charles S. Fuchs, MD
  • Brian P. Findlay, MD
  • Ramesh K. Ramanathan, MD
  • Stephen K. Williamson, MD

Other Information

Sponsor: North Central Cancer Treatment Group
Phase: Phase 3
Trial ID: NCT00003594
Volunteers:  Not Accepting Healthy Volunteers

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