Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00033722
Recruitment Status : Unknown
Verified November 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : August 6, 2003
Last Update Posted : January 6, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Lometrexol may stop or slow the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Folic acid may be effective in preventing or lessening the side effects of lometrexol. Combining lometrexol with folic acid may be an effective treatment for non-small cell lung cancer.

PURPOSE: Phase II trial to study the effectiveness of combining lometrexol with folic acid in treating patients who have stage IIIB or stage IV non-small cell lung cancer that has been previously treated.

Condition or disease Intervention/treatment Phase
Lung Cancer Dietary Supplement: folic acid Drug: lometrexol Phase 2

Detailed Description:


  • Determine the overall response rate in patients with previously treated stage IIIB or IV non-small cell lung cancer when treated with lometrexol and folic acid.
  • Determine the complete response rate, duration of response, and time to progression in patients treated with this regimen.
  • Determine the 1-year survival rate and overall survival in patients treated with this regimen.
  • Determine the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral folic acid once daily on days -7 to 6. Patients also receive lometrexol IV over 30-60 seconds on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed up to 2 months after removal from study and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 50-100 patients will be accrued for this study.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Multicenter Study Of Lometrexol Sodium And Folic Acid In Subjects With Previously Treated Stage IIIB or IV Non-Small Cell Lung Cancer
Study Start Date : February 2002

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed non-small cell lung cancer (NSCLC)

    • Stage IIIB or IV

      • Squamous cell carcinoma
      • Adenocarcinoma
      • Large cell carcinoma
      • Adenosquamous carcinoma
  • Progressive disease after receiving 1 cisplatin- or carboplatin-containing regimen for stage IIIB or IV disease
  • Measurable disease

    • At least 1 lesion at least 1 cm x 1 cm by CT scan either not in a previously irradiated field or showing clear evidence of disease progression after radiation
  • No symptomatic or rapidly increasing, moderate or large amounts of pleural effusion or ascites
  • No prior or concurrent CNS metastases (brain or meningeal)



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months


  • Absolute neutrophil count at least 1,500/mm^3*
  • Platelet count at least 100,000/mm^3*
  • Hemoglobin at least 9.0 g/dL*
  • *Without transfusions or growth factors in the previous 7 days


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN) (regardless of liver involvement secondary to tumor)
  • AST and ALT no greater than 2.5 times ULN (5 times ULN if liver has tumor involvement)


  • Calculated creatinine clearance at least 60 mL/min using Cockroft and Gault formula


  • No inflammatory bowel disease
  • No radiation enteritis
  • No malabsorption syndrome
  • No inability to absorb folic acid


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during study
  • No known untreated vitamin B12 deficiency
  • HIV negative
  • No drug abusers
  • No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No severe concurrent disease or major comorbidity that would preclude study participation


Biologic therapy:

  • At least 3 weeks since prior biologic therapy for NSCLC and recovered from acute side effects
  • Prior treatment with an experimental vaccine allowed
  • No concurrent routine or prophylactic filgrastim (G-CSF), sargramostim (GM- CSF), or epoetin alfa


  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy for NSCLC (6 weeks for mitomycin or nitrosourea) and recovered from acute side effects
  • Prior adjuvant or neoadjuvant chemotherapy allowed

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • Recovered from acute side effects of prior radiotherapy
  • No prior radiotherapy to 25% or more of bone marrow
  • No prior whole pelvic irradiation


  • At least 3 weeks since prior major surgery and recovered


  • At least 3 weeks since prior investigational agent
  • No concurrent proguanil, trimethoprim, co-trimoxazole, or pyrimethamine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00033722

United States, California
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94143-0128
United States, Florida
Cancer Centers of Florida (U.S. Oncology)
Orlando, Florida, United States, 32806
United States, Louisiana
Louisiana State University School of Medicine
New Orleans, Louisiana, United States, 70112-2822
United States, New York
US Oncology - Albany Regional Cancer Center
Albany, New York, United States, 12208
United States, Texas
U.S. Oncology Research Inc.
Houston, Texas, United States, 77060
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Washington
Cancer Care Northwest
Spokane, Washington, United States, 99202
Sponsors and Collaborators
Study Chair: David Tesarowski Tularik Identifier: NCT00033722     History of Changes
Other Study ID Numbers: CDR0000069316
First Posted: August 6, 2003    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: November 2002

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Folic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Folic Acid Antagonists
Enzyme Inhibitors