3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064051
• Other study ID #: VION-CLI-031
• Secondary ID: CDR0000306461
• Status: Completed
• Phase: Phase 2
• First received: July 8, 2003
• Last updated: August 1, 2013
• Start date: January 2003
• Est. completion date: August 2008

Study information

• Verified date: August 2008
• 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: This phase II trial is studying how well giving gemcitabine together with 3-AP works in treating patients with unresectable or metastatic pancreatic cancer.

Description:

OBJECTIVES:

• Determine the objective response rate (partial and complete response) in patients with unresectable or metastatic pancreatic cancer treated with 3-AP and gemcitabine.

• Determine the progression-free interval and survival of patients treated with this regimen.

• Determine the safety and feasibility of this regimen in these patients.

OUTLINE: This is a multicenter study.

• Stage I: Patients receive 3-AP IV over 4 hours and gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

• Stage II: Patients receive a higher dose of 3-AP IV continuously over 24 hours on days 1, 8, and 15. Within 1 hour of completing 3-AP administration, patients receive gemcitabine IV over 30 minutes on days 2, 9, and 16. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month, every 2 months for 6 months, and then every 3 months for 18 months.

PROJECTED ACCRUAL: A total of 50-95 patients will be accrued for this study within 18-24 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: August 2008
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed pancreatic cancer

• Unresectable or metastatic disease

• Measurable disease

• Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy

• No CNS metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

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

• AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases)

• 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 arrhythmias

Pulmonary

• No dyspnea at rest

• No dependence on supplemental oxygen

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study participation

• No other malignancy except any of the following:

• Carcinoma in situ of the cervix treated with cone biopsy or resection

• Nonmetastatic basal cell or squamous cell skin cancer

• Any stage I malignancy curatively resected more than 5 years ago

• No active infection

• No known or suspected glucose-6-phosphate dehydrogenase deficiency

• No other concurrent life threatening illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed

Chemotherapy

• No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy and recovered

• No concurrent radiotherapy

Surgery

• More than 3 weeks since prior surgery and recovered

Other

• More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease

• No other concurrent investigational drugs

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• gemcitabine hydrochloride

• triapine

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Gent	Ghent
United Kingdom	Christie Hospital N.H.S. Trust	Manchester	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Indiana Oncology Hematology Consultants	Indianapolis	Indiana
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,  Belgium,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (partial and complete response) as assessed by RECIST criteria			No
Secondary	Progression-free and overall survival			No
Secondary	Safety and feasibility			Yes