Randomized, Crossover, Pharmacokinetic Study Of Paclitaxel (Taxol) And ABI-007 (A Cremophor EL-Free, Protein Stabilized, Nanoparticle Paclitaxel) In Patients With Advanced Solid Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed malignant solid tumor

- Considered incurable

- Locally advanced or metastatic disease

- Likely to be responsive to taxane-based therapy

- Patients who are refractory to prior paclitaxel are ineligible

- No symptomatic or untreated brain metastasis or carcinomatous meningitis

- No patients who are unable to remain free of corticosteroid therapy for > 4
weeks due to CNS disease

- No previously untreated locally advanced breast cancer

- No hematologic malignancy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 3 months

Hematopoietic

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

Hepatic

- Bilirubin normal

- ALT and AST ≤ 1.5 times upper limit of normal

Renal

- Creatinine normal OR

- Creatinine clearance ≥ 60 mL/min

Cardiovascular

- LVEF ≥ 40%

- No clinical signs or symptoms of heart failure

- No symptomatic congestive heart failure

- No unstable angina pectoris

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 2 months after study
participation

- No history of allergic reaction attributed to compounds of similar chemical or
biologic composition to paclitaxel (e.g., docetaxel, Cremophor^® EL [CrEL],
polysorbate 80 [Tween 80], or CrEL-containing medications [e.g., cyclosporine])

- No history of seizure disorder requiring anticonvulsant therapy

- No active serious infection

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

- No concurrent filgrastim (G-CSF) during courses 1 and 2

Chemotherapy

- See Disease Characteristics

- At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

- No other concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- At least 2 weeks since prior hormonal therapy

- Concurrent luteinizing hormone-releasing hormone agonists for prostate cancer allowed

Radiotherapy

- At least 3 weeks since prior radiotherapy

- No concurrent radiotherapy

Surgery

- Not specified

Other

- More than 2 weeks since prior drugs, herbal preparations, or dietary supplements
known to influence CYP3A4 (e.g., phenytoin, rifampin, Hypericum perforatum [St.
John's wort], garlic supplements, or grapefruit juice) and/or CYP2C8

- No concurrent substances known or likely to interfere with the pharmacokinetics of
paclitaxel (e.g., verapamil or cyclosporine)

- No other concurrent investigational agents

- No other concurrent anticancer therapy