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Drug/Agent Toxicity by Tissue/OrganPhase 1NCT00024310

Paclitaxel, Folic Acid, and Lometrexol in Treating Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1 study testing folic acid, lometrexol and paclitaxel in people with Drug/Agent Toxicity by Tissue/Organ and Unspecified Adult Solid Tumor, Protocol Specific, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
folic acid, lometrexol and paclitaxel
How many people
Not given
Where
1 siteUnited States
Study dates
Sep 2001to not given
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

Other trials in United States

About this study

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

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.

Read the detailed description

OBJECTIVES:

  • 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.
  • Determine the quantitative and qualitative toxic effects of this regimen in these patients.
  • Determine the plasma concentrations of lometrexol and paclitaxel and relate their pharmacokinetics to toxicity outcome in these patients.
  • Determine the antitumor activity of this regimen in these patients.

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.

Being tested
folic acid, lometrexol, paclitaxel
Keywords
unspecified adult solid tumor, protocol specific, drug/agent toxicity by tissue/organ
Medical subject headings
Drug-Related Side Effects and Adverse Reactions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • folic acidDietary supplement

  • lometrexolDrug

  • paclitaxelDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2003 (estimated)
  2. Study startSep 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00024310
Sponsor's protocol ID
CDR0000068917
Other IDs
UCLA-0005068, TULA-T3004, NCI-G01-2017
Status last verified
Nov 2002
First submitted
13 Sep 2001
Last updated
17 Sep 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing folic acid, lometrexol and paclitaxel in people with Drug/Agent Toxicity by Tissue/Organ and Unspecified Adult Solid Tumor, Protocol Specific, run by Jonsson Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.

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