|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Jonsson Comprehensive Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00024310 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Unspecified Adult Solid Tumor, Protocol Specific |
Dietary Supplement: folic acid Drug: lometrexol Drug: paclitaxel |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase I Trial of Lometrexol Sodium and Paclitaxel Adminsitered Intravenously Every 21 Days in Conjunction With Oral Folic Acid in Patients With Solid Tumors |
| Study Start Date: | September 2001 |
OBJECTIVES:
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Study Chair: | Lee S. Rosen, MD | Jonsson Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000068917, UCLA-0005068, TULA-T3004, NCI-G01-2017 |
| Study First Received: | September 13, 2001 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00024310 History of Changes |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific drug/agent toxicity by tissue/organ |
|
Antimetabolites Lometrexol Vitamin B Complex Hematinics Folate Trace Elements Antimitotic Agents Folinic Acid |
Folic Acid Antagonists Vitamin B9 Folic Acid Paclitaxel Vitamins Tubulin Modulators Micronutrients Antineoplastic Agents, Phytogenic |
|
Antimetabolites Lometrexol Vitamin B Complex Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hematinics Growth Substances Mitosis Modulators Physiological Effects of Drugs Hematologic Agents |
Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Pharmacologic Actions Folic Acid Paclitaxel Vitamins Therapeutic Uses Tubulin Modulators Micronutrients Antineoplastic Agents, Phytogenic |