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Home > "P" Clinical Trials Conditions > Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors  Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
For Condition: Drug Toxicity,unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Folic acid may protect normal cells from the side effects of chemotherapy and may increase the effectiveness of chemotherapy by making tumor cells more sensitive to the drug. Lometrexol may stop the growth of tumors by blocking one of the enzymes necessary for cancer cell growth. Combining chemotherapy with folic acid and lometrexol may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining paclitaxel, folic acid, and lometrexol in treating patients who have locally advanced or metastatic solid tumors.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II study dose of lometrexol and paclitaxel when combined with folic acid in patients with locally advanced or metastatic solid tumors. II. Determine the quantitative and qualitative toxic effects of this regimen in these patients. III. Determine the plasma concentrations of lometrexol and paclitaxel and relate their pharmacokinetics to toxicity outcome in these patients. IV. Determine the antitumor activity of this regimen in these patients. PROTOCOL OUTLINE: This is a multicenter, dose-escalation study of lometrexol and paclitaxel. Patients receive lometrexol IV over 30-60 seconds immediately followed by paclitaxel IV over 3 hours on day 1. Patients also receive oral folic acid beginning 7 days before lometrexol/paclitaxel and continuing for 14 days. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Doses of lometrexol and paclitaxel are escalated sequentially. Cohorts of 3-6 patients receive escalating doses of lometrexol and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. Six to twelve additional patients are treated at the recommended phase II study dose (dose immediately preceding the MTD). Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 12-42 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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/mm3* - Platelet count at least 100,000/mm3* - 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 - No body surface area greater than 3.0 m2 - No known vitamin B12 deficiency
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LeeRosen, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000068917; UCLA-0005068,NCI-G01-2017,TULA-T3004
Study Start Date: September 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024310
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. KRN7000 in Treating Patients With Solid Tumors
2. E7070 in Treating Patients With Solid Tumors
3. Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
4. BMS-214662 in Treating Patients With Advanced Solid Tumors
5. LY293111 in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors
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