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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT00009932
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Histologically or cytologically proven refractory solid tumor for which paclitaxel and cisplatin are reasonable therapeutic options
* No active CNS disease
* CNS metastasis allowed if measurable disease outside of the CNS and patient completed and recovered from 1 prior course of CNS radiotherapy (if clinically indicated)
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2 OR
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Platelet count at least 100,000/mm3
* Absolute neutrophil count at least 1,500/mm3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* ALT and AST no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if related to liver metastases)
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No severe symptomatic cardiac disease
Other:
* No clinically significant/evident retinopathy
* No other malignancy within the past 5 years except localized nonmelanoma skin cancer or carcinoma in situ of the cervix
* No uncontrolled infection
* No other significant medical or psychiatric condition that would increase risk
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception for 1 month before, during, and for at least 2 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* No prior paclitaxel, cisplatin, or fenretinide
* At least 4 weeks since other prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy to only site of measurable/evaluable disease
* No prior radiotherapy to more than 25% of bone marrow
Surgery:
* At least 2 weeks since prior therapeutic surgery and recovered
Other:
* At least 4 weeks since prior routine vitamin A of at least 10,000 IU/ day or beta carotene of at least 10 mg/day
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00009932
Study Brief:
Protocol Section:
NCT00009932