Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00100815
First received: January 6, 2005
Last updated: March 5, 2012
Last verified: March 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Giving gemcitabine and capecitabine together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine and capecitabine together with bevacizumab works in treating patients with metastatic or unresectable pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Biological: bevacizumab
Drug: capecitabine
Drug: gemcitabine hydrochloride
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: every 2-4 months for 1 year and then every 6 months for at least 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: assessed at baseline then weekly for 3 weeks ] [ Designated as safety issue: No ]
  • Clinical response [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2004
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: bevacizumab
    30-90 minutes on day 1, every 21 days up to 12 months.
    Drug: capecitabine
    twice daily on days 1-14. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
    Drug: gemcitabine hydrochloride
    IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
Detailed Description:

OBJECTIVES:

Primary

  • Determine progression-free survival of patients with metastatic or unresectable adenocarcinoma of the pancreas treated with gemcitabine, capecitabine, and bevacizumab.

Secondary

  • Determine clinical response in patients treated with this regimen.
  • Determine toxicity of this regimen in these patients.
  • Determine quality of life of patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients receive bevacizumab IV over 30-90 minutes on day 1, oral capecitabine twice daily on days 1-14, and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline then weekly for 3 weeks.

Patients are followed every 2-4 months for 1 year and then every 6 months for at least 5 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within 8.8-17.5 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the pancreas meeting 1 of the following criteria:

    • Newly diagnosed or previously treated metastatic disease
    • Unresectable disease
  • No CNS or brain metastases

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • WBC > 3,000/mm^3
  • Platelet count > 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)
  • No evidence of bleeding diathesis or coagulopathy

Hepatic

  • Bilirubin < 2 mg/dL
  • AST or ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • INR < 1.5 (except for patients receiving full-dose warfarin)

Renal

  • Creatinine < 1.5 mg/dL
  • No proteinuria OR
  • Urine protein < 500 mg by 24-hour urine collection
  • No clinically significant impairment of renal function

Cardiovascular

  • No uncontrolled hypertension (blood pressure > 160/110 mm Hg on medication)
  • No New York Heart Association class II-IV congestive heart failure
  • No unstable symptomatic arrhythmia requiring medication

    • Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
  • No clinically significant grade II-IV peripheral vascular disease
  • No arterial thromboembolic event within the past 6 months, including any of the following:

    • Transient ischemic attack
    • Cerebrovascular accident
    • Unstable angina
    • Myocardial infarction

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious systemic disease
  • No significant traumatic injury within the past 28 days
  • No serious non-healing wound, ulcer, or bone fracture
  • No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since prior fine needle aspirations or core biopsies
  • No concurrent major surgery

Other

  • More than 4 weeks since prior and no concurrent participation in any other experimental drug study
  • More than 12 months since prior adjuvant therapy
  • No prior systemic therapy for metastatic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100815

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-1714
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Renuka Iyer, MD Roswell Park Cancer Institute
  More Information

Additional Information:
Publications:
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00100815     History of Changes
Other Study ID Numbers: CDR0000409556, RPCI-I-19903, GENENTECH-RPCI-I-19903
Study First Received: January 6, 2005
Last Updated: March 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Roswell Park Cancer Institute:
adenocarcinoma of the pancreas
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
Bevacizumab
Gemcitabine
Capecitabine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014