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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT00003569
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed non-small cell lung cancer, ovarian carcinoma, squamous cell carcinoma of the head and neck, tumor types for which no standard treatment exists, or tumor types that have failed standard therapy
* Paclitaxel and cisplatin combination therapy must be an appropriate option in treating disease
* No potentially curable type of cancer (e.g., newly diagnosed testicular cancer)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 6 weeks
Hematopoietic:
* WBC greater than 4,000/mm\^3
* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
Hepatic:
* Bilirubin normal
* SGOT and SGPT normal
Renal:
* Creatinine normal
* Creatinine clearance at least 60 mL/min
Cardiovascular:
* No evidence of congestive heart failure
* No uncontrolled moderate to severe hypertension
* Includes patients with persistent elevated systolic blood pressures of greater than 170 mm Hg and diastolic blood pressures of greater than 100 mm Hg for more than 1 month while under medical treatment
Other:
* No active infection
* No perceived or actual clinical risk of cisplatin induced toxicity that exceeds the clinical benefit of using cisplatin therapy
* No known history of severe hypersensitivity to polyoxyl 35 castor oil vehicle
* No severe medical problems unrelated to malignancy that would interfere with compliance in this study
* Not pregnant
* Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent colony stimulating factors except for febrile neutropenia
* No concurrent aminoglycoside therapy except for febrile neutropenia or other life threatening infections
* No concurrent immunotherapy
Chemotherapy:
* At least 6 weeks since prior nitrosoureas or mitomycin
* At least 3 weeks since other prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* No prior radiotherapy to measurable disease
Surgery:
* At least 2 weeks since prior major surgery
Other:
* No other concurrent investigational agents
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00003569
Study Brief:
Protocol Section:
NCT00003569