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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064064
• Other study ID #: CDR0000306462
• Secondary ID: VION-CLI-030MDA-
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2003
• Last updated: November 5, 2013
• Start date: January 2003
• Est. completion date: August 2008

Study information

• Verified date: August 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• gemcitabine hydrochloride

• triapine

Locations

Country	Name	City	State
Netherlands	University Medical Center Nijmegen	Nijmegen
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota
United States	Sarah Cannon Cancer Center at Centennial Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vion Pharmaceuticals

Countries where clinical trial is conducted

United States,  Netherlands,