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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
folic acid
lometrexol
Sponsored by
Tularik
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Cancer Center and Cancer Research Institute
  • Cancer Centers of Florida (U.S. Oncology)
  • Louisiana State University School of Medicine
  • US Oncology - Albany Regional Cancer Center
  • U.S. Oncology Research Inc.
  • Tyler Cancer Center
  • Cancer Care Northwest

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 9, 2002
Last Updated
January 3, 2014
Sponsor
Tularik
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1. Study Identification

Unique Protocol Identification Number
NCT00033722
Brief Title
Lometrexol Plus Folic Acid in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
November 2002
Overall Recruitment Status
Unknown status
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Tularik

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
folic acid
Intervention Type
Drug
Intervention Name(s)
lometrexol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Tesarowski
Organizational Affiliation
Tularik
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
Cancer Centers of Florida (U.S. Oncology)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Louisiana State University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2822
Country
United States
Facility Name
US Oncology - Albany Regional Cancer Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
U.S. Oncology Research Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77060
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

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

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