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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT00087334
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed\* colorectal cancer
* Metastatic disease
* The site of the primary tumor must have been confirmed endoscopically, radiologically, or surgically to be the colon or rectum NOTE: \*Confirmation is not required for recurrent metastatic disease unless an interval of \> 5 years has elapsed between the initial primary surgery and the development of metastases
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* No CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 to 80
Performance status
* ECOG 0-1
Life expectancy
* More than 3 months
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL (transfusion allowed)
Hepatic
* AST and ALT ≤ 3 times upper limit of normal (ULN)
* Bilirubin ≤ ULN
* No unstable or uncompensated hepatic disease
Renal
* Creatinine \< 1.5 times ULN OR
* Creatinine clearance \> 60 mL/min
* No unstable or uncompensated renal disease
Cardiovascular
* No unstable or uncompensated cardiac disease
Pulmonary
* No evidence of clinically active interstitial lung disease
* Asymptomatic patients with chronic stable radiographic changes are eligible
* No unstable or uncompensated respiratory disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study participation
* No known hypersensitivity to gefitinib or any of its excipients
* No known hypersensitivity to platinum compounds, fluorouracil, or capecitabine
* No severe or uncontrolled systemic disease
* Able to receive oral medication
* No known dihydropyrimidine dehydrogenase (DPD) deficiency
* No known peripheral neuropathy ≥ grade 1
* Absence of deep tendon reflexes as the sole neurological abnormality allowed
* No other significant clinical disorder or laboratory finding that would preclude study participation
* No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix (phase II only)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 4 weeks since prior chemotherapy for metastatic colorectal cancer (phase I)
* No prior chemotherapy for metastatic disease (phase II)
* Prior fluorouracil and leucovorin calcium in the adjuvant setting allowed provided the last treatment was administered more than 6 months before the development of metastatic disease
* No prior irinotecan and oxaliplatin (phase II)
Endocrine therapy
* Not specified
Radiotherapy
* No concurrent radiotherapy for colorectal cancer
Surgery
* See Disease Characteristics
* More than 4 weeks since prior major surgery (e.g., laparotomy)
Other
* Recovered from all prior therapy (no unresolved chronic toxicity \> grade 2)
* More than 4 weeks since prior investigational drugs
* No prior epidermal growth factor receptor inhibitor therapy (phase II)
* No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum perforatum (St. John's wort)
* No other concurrent investigational drugs
* No other concurrent systemic therapy for colorectal cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00087334
Study Brief:
Protocol Section:
NCT00087334