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

Sponsor:	Vion Pharmaceuticals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00064051

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Drug: gemcitabine hydrochloride Drug: triapine	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride 3-Aminopyridine-2-carboxaldehyde thiosemicarbazone

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Objective response rate (partial and complete response) as assessed by RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free and overall survival [ Designated as safety issue: No ]
Safety and feasibility [ Designated as safety issue: Yes ]

Study Start Date:	January 2003
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00064051

Locations

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
Indiana Oncology Hematology Consultants
Indianapolis, Indiana, United States, 46202
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Tennessee
Sarah Cannon Cancer Center at Centennial Medical Center
Nashville, Tennessee, United States, 37203
Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium, B-9000
United Kingdom
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT

Sponsors and Collaborators

Vion Pharmaceuticals

Investigators

Study Chair:

Mario Sznol, MD

Vion Pharmaceuticals

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00064051 History of Changes
Other Study ID Numbers:	CDR0000306461, VION-CLI-031
Study First Received:	July 8, 2003
Last Updated:	August 23, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II pancreatic cancer
stage III pancreatic cancer
recurrent pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on February 12, 2012