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

V

Vion Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: gemcitabine hydrochloride
Drug: triapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00064051
VION-CLI-031
CDR0000306461 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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