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:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT00004159
Eligibility Criteria:
DISEASE CHARACTERISTICS: Phase I portion (closed for accrual after the maximum tolerated dose and dose limiting toxicity were determined) Histologically or cytologically confirmed advanced non-small cell lung cancer (NSCLC) or other solid tumor for which no standard curative treatment exists Phase II portion (open for accrual): Histologically proven stage IV NSCLC without prior chemotherapy Measurable or evaluable disease No primary brain tumors Brain metastases allowed if controlled by radiation or stereotactic radiosurgery No lymphoproliferative disease No HIV related malignancies
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No congestive heart failure Other: Not pregnant or nursing Fertile patients must use effective contraception No serious nonmalignant disease No active/uncontrolled infection or bleeding (e.g., active peptic ulcer disease) No other primary malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No allergy to Cremophor
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Phase I: No prior paclitaxel or gemcitabine At least 3 weeks since other prior chemotherapy and recovered Phase II: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00004159
Study Brief:
Protocol Section:
NCT00004159