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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00033722
First received: April 9, 2002
Last updated: January 3, 2014
Last verified: November 2002
  Purpose

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 Intervention Phase
Lung Cancer
Dietary Supplement: folic acid
Drug: lometrexol
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2002
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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)

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • At least 3 months

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*
  • *Without transfusions or growth factors in the previous 7 days

Hepatic:

  • 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)

Renal:

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

Gastrointestinal:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

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

Chemotherapy:

  • 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

Radiotherapy:

  • 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

Surgery:

  • At least 3 weeks since prior major surgery and recovered

Other:

  • At least 3 weeks since prior investigational agent
  • No concurrent proguanil, trimethoprim, co-trimoxazole, or pyrimethamine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00033722

Locations
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
Tularik
Investigators
Study Chair: David Tesarowski Tularik
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00033722     History of Changes
Other Study ID Numbers: CDR0000069316, TULA-T064031, USO-01103
Study First Received: April 9, 2002
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

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
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lometrexol
Folic Acid
Vitamin B Complex
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Folic Acid Antagonists
Enzyme Inhibitors
Hematinics
Hematologic Agents
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014