Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT00003594
Eligibility Criteria:
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 agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003594
Study Brief:
Protocol Section:
NCT00003594