Gemcitabine, Cisplatin, and Bevacizumab in Treating Patients With Metastatic Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00126633
First received: August 2, 2005
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving gemcitabine and cisplatin together with bevacizumab may kill more tumor cells.

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


Condition Intervention Phase
Pancreatic Cancer
Biological: bevacizumab
Drug: cisplatin
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: A Study of Fixed-Dose Rate Gemcitabine, Cisplatin, and Bevacizumab in Previously Untreated Patients With Metastatic Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Time to progression [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity as measured by NCI CTC version 2.0 [ Designated as safety issue: Yes ]
  • Micrometastases for predicting time to progression and overall survival [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: April 2004
Study Completion Date: October 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine time to disease progression in patients with previously untreated metastatic adenocarcinoma of the pancreas treated with gemcitabine, cisplatin, and bevacizumab.
  • Determine the safety and toxicity of this regimen in these patients.

Secondary

  • Determine the objective response rate in patients treated with this regimen.
  • Determine the efficacy of this regimen, in terms of the proportion of patients with ≥ a 50% decline in the CA19-9 biomarker, in these patients.
  • Determine the median survival of patients treated with this regimen.
  • Correlate serum markers of angiogenesis and circulating tumor micrometastases with clinical outcome of patients treated with this regimen.

OUTLINE: This is an open-label, non-randomized study.

Patients receive gemcitabine IV over 100 minutes, cisplatin IV over 30-60 minutes, and bevacizumab* IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional study treatment at the discretion of the investigator.

NOTE: *Patients may continue to receive other components of therapy if bevacizumab is discontinued due to toxicity.

After completion of study treatment, patients are followed at 28 days and then monthly thereafter.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 12-18 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 adenocarcinoma of the pancreas

    • Must have documented extrapancreatic metastases

      • Radiographically measurable disease is not required
  • Previously untreated disease
  • No CNS or brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

  • INR ≤ 1.5 (except for patients receiving full-dose warfarin)
  • Bilirubin ≤ 2.0 mg/dL
  • AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)

Renal

  • Creatinine ≤ 2.0 mg/dL
  • Urine protein:creatinine ratio ≤ 1

Cardiovascular

  • No New York Heart Association class II-IV congestive heart failure
  • No myocardial infarction or stroke within the past 6 months
  • No uncontrolled hypertension (i.e., blood pressure > 160/110 mm Hg despite antihypertensive therapy)
  • No unstable angina
  • No unstable symptomatic arrhythmia requiring medication

    • Patients with chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are eligible
  • No peripheral vascular disease ≥ grade 2

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • No significant traumatic injury within the past 28 days
  • No serious non-healing wound, ulcer, or bone fracture
  • No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No other serious systemic disease
  • No history of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would preclude study treatment

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

  • No prior therapy, including systemic or investigational therapy, for locally advanced or metastatic pancreatic cancer

    • Treatment given in the adjuvant setting (e.g., radiotherapy and/or chemotherapy, given either concurrently or systemically) is not considered prior therapy provided progressive disease occurred > 6 months after completion of prior treatment
  • Concurrent continuation of therapeutic doses of warfarin or low-molecular weight heparin allowed for pulmonary embolism, deep vein thrombosis, atrial fibrillation, or other clinical indications provided patients has been on a stable dose for ≥ 28 days with no further clotting or bleeding complications
  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: NCT00126633

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Andrew Ko, MD University of California, San Francisco
  More Information

Additional Information:
Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00126633     History of Changes
Other Study ID Numbers: CDR0000437858, UCSF-04451, GENENTECH-AVF2937s
Study First Received: August 2, 2005
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, San Francisco:
adenocarcinoma of the pancreas
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
Bevacizumab
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014