Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

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


- 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

- 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

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

Inclusion Criteria


- 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

- 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


- 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


Biologic therapy:

- At least 3 weeks since prior biologic therapy for NSCLC and recovered from acute side

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David Tesarowski

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

February 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Louisiana State University School of Medicine New Orleans, Louisiana  70112-2822
U.S. Oncology Research Inc. Houston, Texas  77060
Tyler Cancer Center Tyler, Texas  75702
Cancer Care Northwest Spokane, Washington  99202
Cancer Centers of Florida (U.S. Oncology) Orlando, Florida  32806
US Oncology - Albany Regional Cancer Center Albany, New York  12208