NCT00024310

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2001

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

June 20, 2003

Completed
Last Updated

September 17, 2013

Status Verified

November 1, 2002

First QC Date

September 13, 2001

Last Update Submit

September 16, 2013

Conditions

Drug/Agent Toxicity by Tissue/OrganUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificdrug/agent toxicity by tissue/organ

Interventions

folic acidDIETARY_SUPPLEMENT
lometrexolDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Folic AcidlometrexolPaclitaxel

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Lee S. Rosen, MD

    Jonsson Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2001

First Posted

June 20, 2003

Study Start

September 1, 2001

Last Updated

September 17, 2013

Record last verified: 2002-11

Locations

US(1)