Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Drug/Agent Toxicity by Tissue/Organ, Unspecified Adult Solid Tumor, Protocol Specific
About this trial
This is an interventional treatment trial for Drug/Agent Toxicity by Tissue/Organ focused on measuring unspecified adult solid tumor, protocol specific, drug/agent toxicity by tissue/organ
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven locally advanced or metastatic solid tumor that is refractory to standard therapies or for which there are no therapies of potential major benefit Measurable disease No hematologic malignancies, including leukemia, lymphoma, or multiple myeloma No symptomatic effusions or ascites unless drained before study entry No clinically apparent CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3* Platelet count at least 100,000/mm^3* Hemoglobin at least 9.0 g/dL* NOTE: * Without growth factor support Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT and SGPT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if tumor involvement of liver) Albumin greater than 2.5 g/dL Renal: Glomerular filtration rate at least 65 mL/min Gastrointestinal: No inflammatory bowel disease No radiation enteritis No malabsorption syndrome Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known hypersensitivity to study drugs or related compounds (e.g., LY309887, multi-targeted antifolate, AG-2034, methotrexate, docetaxel, or polyoxyethylated castor oil) No active uncontrolled infection unless approved by the investigator No other severe concurrent disease that would preclude study therapy No body surface area greater than 3.0 m^2 No known vitamin B12 deficiency PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent routine or prophylactic filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa No concurrent biologic-response modifiers Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin, carboplatin, or nitrosourea) and recovered No other concurrent cytotoxic chemotherapy Endocrine therapy: No concurrent hormonal therapy Radiotherapy: Recovered from prior radiotherapy No prior radiotherapy to 25% or more of bone marrow (e.g., whole-pelvic irradiation) No concurrent radiotherapy (including palliative radiotherapy) Surgery: At least 4 weeks since prior major surgery and recovered Other: At least 4 weeks since prior investigational agent No more than 2 prior therapies for locally advanced or metastatic solid tumor No other concurrent investigational agent No concurrent trimethoprim, co-trimoxazole, proguanil, or pyrimethamine
Sites / Locations
- Jonsson Comprehensive Cancer Center, UCLA