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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
gemcitabine hydrochloride
triapine
Sponsored by
Vion Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago Cancer Research Center
  • Indiana Oncology Hematology Consultants
  • University of Minnesota Cancer Center
  • Sarah Cannon Cancer Center at Centennial Medical Center
  • Universitair Ziekenhuis Gent
  • Christie Hospital N.H.S. Trust
  • Royal Marsden NHS Foundation Trust - Surrey

Outcomes

Primary Outcome Measures

Objective response rate (partial and complete response) as assessed by RECIST criteria

Secondary Outcome Measures

Progression-free and overall survival
Safety and feasibility

Full Information

First Posted
July 8, 2003
Last Updated
August 1, 2013
Sponsor
Vion Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00064051
Brief Title
3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Official Title
A Phase II Study of Triapine in Combination With Gemcitabine in Patients With Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vion Pharmaceuticals

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
triapine
Primary Outcome Measure Information:
Title
Objective response rate (partial and complete response) as assessed by RECIST criteria
Secondary Outcome Measure Information:
Title
Progression-free and overall survival
Title
Safety and feasibility

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Sznol, MD
Organizational Affiliation
Vion Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Indiana Oncology Hematology Consultants
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Sarah Cannon Cancer Center at Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

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

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