3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
This study has been completed.
Sponsor:
Vion Pharmaceuticals
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00064051
First received: July 8, 2003
Last updated: August 23, 2008
Last verified: August 2008
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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 2 |
| 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:
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) |
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:
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 May 16, 2013