Immediate Compared With Delayed Chemotherapy in Treating Patients With Advanced Colorectal Cancer Without Signs or Symptoms of Disease

This study has been completed.
Sponsor:
Collaborator:
North Central Cancer Treatment Group
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00002570
First received: November 1, 1999
Last updated: September 20, 2012
Last verified: September 2011
  Purpose

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 treatment regimen is more effective for colorectal cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of immediate with delayed fluorouracil plus leucovorin in treating patients with advanced colorectal cancer without signs or symptoms of disease.


Condition Intervention Phase
Colorectal Cancer
Drug: fluorouracil
Drug: leucovorin calcium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE III STUDY OF IMMEDIATE VERSUS DELAYED CHEMOTHERAPY FOR ASYMPTOMATIC ADVANCED COLORECTAL CANCER

Resource links provided by NLM:


Further study details as provided by NCIC Clinical Trials Group:

Primary Outcome Measures:
  • Survival [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 8 years ] [ Designated as safety issue: Yes ]
  • Time to progression [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • response rate [ Time Frame: 8 years ] [ Designated as safety issue: No ]
  • response duration [ Time Frame: 8 years ] [ Designated as safety issue: No ]

Enrollment: 67
Study Start Date: July 1994
Study Completion Date: February 2009
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluorouracil and folinic acid Drug: fluorouracil
425 mg/m2 IV by bolus injection daily for 5 consecutive days q 28 days
Drug: leucovorin calcium
20 mg/m2 IV - number of cycles is determined by patient and physician
No Intervention: Observation

Detailed Description:

OBJECTIVES: I. Compare survival and quality of life in asymptomatic patients with advanced colorectal cancer randomized to immediate fluorouracil/leucovorin (5-FU/CF) vs. 5-FU/CF delayed until onset of symptoms.

OUTLINE: Randomized, unblinded study. Arm I: Single-Agent Chemotherapy with Drug Modulation. Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, CF, NSC-3590. Arm II: Observation followed by Single-Agent Chemotherapy with Drug Modulation. Clinical observation until symptomatic; followed by 5-FU; with CF.

PROJECTED ACCRUAL: 144 patients will be entered over 4 years.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cancer of the colon or rectum that is locally advanced or metastatic Primary lesion was or is located in the large bowel as confirmed by endoscopy, radiology, or surgery Radiologic or clinical evidence of metastasis subsequent to resection does not require histologic or cytologic confirmation unless: Interval between primary surgery and development of metastasis is greater than 5 years OR Primary cancer was Dukes' A or B1 Ineligible for potentially curative therapy, e.g.: Surgical resection of a limited hepatic or pulmonary metastasis Irradiation of locally recurrent colon or rectal cancer No or minimal symptoms related to the cancer, i.e.: No persistent pain requiring regular narcotic analgesia No persistent fever greater than 38 degrees C No symptomatic bowel obstruction No persistent nausea requiring medication No weight loss of greater than 5 kg over the previous 3 months unless clearly not associated with the cancer (e.g., associated with surgery or intercurrent illness) Symptomatic relapse/metastases rendered asymptomatic by secondary surgery or radiotherapy are eligible provided the patient remains asymptomatic for at least 6 weeks following such treatment No CNS metastases No significant ascites, pleural effusion, or pericardial effusion

PATIENT CHARACTERISTICS: Age: Adult under 80 (i.e., of legal age to sign own informed consent according to institutional policy) Performance status: Karnofsky 90-100% ECOG 0 Hematopoietic: Granulocytes at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal Renal: Creatinine less than 2.26 mg/dL Cardiovascular: No arrhythmia Other: No infection No other medical condition that is uncontrolled or could be aggravated by the protocol therapy No prior or concurrent second cancer except: Nonmelanomatous skin cancer In situ cervical cancer No pregnant women Adequate contraception required of fertile patients Blood/body fluid analyses to determine eligibility and quality-of-life questionnaire completed within 14 days prior to randomization; imaging studies of sites of disease completed within 28 days prior to randomization

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for metastatic disease or local recurrence Prior fluorouracil-based or other adjuvant therapy allowed At least 6 months required between completion of therapy and documentation of metastasis or recurrence Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Prior surgery allowed

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002570

Locations
United States, Arizona
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 10309-1016
Siouxland Hematology-Oncology
Sioux City, Iowa, United States, 51101-1733
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CentraCare Clinic
Saint Cloud, Minnesota, United States, 56303
United States, North Dakota
Quain & Ramstad Clinic, P.C.
Bismarck, North Dakota, United States, 58501
CCOP - Merit Care Hospital
Fargo, North Dakota, United States, 58122
Altru Health Systems
Grand Forks, North Dakota, United States, 58201
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57105-1080
Sponsors and Collaborators
NCIC Clinical Trials Group
North Central Cancer Treatment Group
Investigators
Study Chair: Malcolm J. Moore, MD Princess Margaret Hospital, Canada
Study Chair: Henry C. Pitot, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Hummer A, Carlo W, Sullivan D, et al.: Extensive hepatic resection does not correlate with toxicity following adjuvant chemotherapy. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-526, 2002.

Responsible Party: NCIC Clinical Trials Group
ClinicalTrials.gov Identifier: NCT00002570     History of Changes
Other Study ID Numbers: CO10, CAN-NCIC-CO10, NCCTG-JCO10, NCCTG-JCO.10, NCI-V94-0463, CDR0000063607
Study First Received: November 1, 1999
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

Keywords provided by NCIC Clinical Trials Group:
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on July 20, 2014