3-AP and Gemcitabine in Treating Patients With Metastatic Non-Small Cell Lung Cancer

V

Vion Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Lung Cancer

Treatments

Drug: gemcitabine hydrochloride
Drug: triapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00064064
CDR0000306462
VION-CLI-030
MDA-ID-030143

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy such as gemcitabine use different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and may help gemcitabine kill more cancer cells by making them more sensitive to the drug. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with 3-AP in treating patients who have metastatic non-small cell lung cancer.

Full description

OBJECTIVES: Determine the partial and complete objective response rate in patients with metastatic non-small cell lung cancer treated with 3-AP and gemcitabine. Determine the progression-free and overall survival in patients treated with this regimen. Determine the safety of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive 3-AP IV over 4 hours followed by gemcitabine IV over 30 minutes once weekly on weeks 1-3. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 22-50 patients will be accrued for this study.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer

Metastatic disease

Progressive disease after no more than 2 prior cytotoxic regimens containing at least 1 of the following drugs:

  • Cisplatin
  • Carboplatin
  • Taxane
  • Vinorelbine
  • Measurable disease
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

ECOG 0-1

Life expectancy

More than 3 months

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic

  • Bilirubin no greater than 2.0 mg/dL
  • ALT and AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • Chronic viral hepatitis allowed

Renal

Creatinine no greater than 2.0 mg/dL

Cardiovascular

  • No myocardial infarction within the past 3 months
  • No uncontrolled congestive heart failure
  • No uncontrolled coronary artery disease
  • No uncontrolled cardiac arrhythmias

Pulmonary

  • No dyspnea at rest
  • No supplemental oxygen dependence

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No active infection
  • No other prior or concurrent malignancy except carcinoma in situ of the cervix previously treated by cone biopsy and/or resection, nonmetastatic basal cell or squamous cell skin cancer, or any stage I malignancy curatively resected more than 5 years ago
  • No other concurrent life-threatening illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

Prior non-cytotoxic biologic regimens allowed (e.g., vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors)

Chemotherapy

  • See Disease Characteristics
  • More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior gemcitabine
  • No prior 3-AP

Endocrine therapy

Not specified

Radiotherapy

More than 4 weeks since prior radiotherapy and recovered

Surgery

More than 3 weeks since prior surgery and recovered

Other

More than 3 weeks since prior non-cytotoxic regimens

Trial contacts and locations

5

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems