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A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Metastatic Non-Small Cell Lung Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mario Sznol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vion Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000306462

NCT ID:

NCT00064064

Start Date:

January 2003

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Sarah Cannon Cancer Center at Centennial Medical CenterNashville, Tennessee  37203