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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
N/A
Open (Enrolling)
Both
Lung Cancer

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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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

David Tesarowski

Investigator Role:

Study Chair

Investigator Affiliation:

Tularik

Authority:

United States: Federal Government

Study ID:

CDR0000069316

NCT ID:

NCT00033722

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

Name

Location

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