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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00112528
First received: June 2, 2005
Last updated: November 5, 2010
Last verified: July 2006

June 2, 2005
November 5, 2010
June 2005
November 2010   (final data collection date for primary outcome measure)
Survival at 6 months [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00112528 on ClinicalTrials.gov Archive Site
  • Objective response rate as measured by RECIST criteria [ Designated as safety issue: No ]
  • Median survival [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to treatment failure [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Bevacizumab, Gemcitabine, and Oxaliplatin in Treating Patients With Metastatic Pancreatic Cancer
Phase II Trial of Bevacizumab, Gemcitabine, Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma

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

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

OBJECTIVES:

Primary

  • Determine the 6-month survival of patients with metastatic adenocarcinoma of the pancreas treated with bevacizumab, gemcitabine, and oxaliplatin.

Secondary

  • Determine the objective response rate in patients with measurable disease treated with this regimen.
  • Determine median survival, progression-free survival, time to treatment failure, and overall survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 100 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15. Patients also receive oxaliplatin IV over 120 minutes on days 2 and 16. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 courses of therapy beyond CR.

After completion of study treatment, patients are followed every 3-6 months for up to 5 years.

PROJECTED ACCRUAL: A total of 83 patients will be accrued for this study within 9 months.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Cancer
  • Biological: bevacizumab
  • Drug: gemcitabine hydrochloride
  • Drug: oxaliplatin
Not Provided
Kim GP, Alberts SR, Oberg AL, et al.: Phase II trial of bevacizumab, gemcitabine, and oxaliplatin in patients with metastatic pancreatic adenocarcinoma. [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-169, 2007.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
Not Provided
November 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed ductal cell or undifferentiated adenocarcinoma of the pancreas

    • Previously untreated metastatic disease
  • No islet cell or acinar cell carcinoma or cystadenocarcinoma
  • No invasion of adjacent organs (i.e., duodenum or stomach) or major blood vessels ( i.e., superior mesenteric artery or celiac artery)
  • No CNS metastasis

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10.0 g/dL
  • No bleeding diathesis or uncontrolled coagulopathy
  • No bleeding events within the past 6 months

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN) (stenting allowed)
  • AST ≤ 5 times ULN
  • No esophageal varices

Renal

  • Creatinine ≤ 2 times ULN
  • Proteinuria < 1+ by dipstick or urinalysis OR
  • Protein < 1 g/24-hr urine collection
  • No nephrotic syndrome

Cardiovascular

  • No New York Heart Association class II-IV congestive heart failure
  • No symptomatic, unstable angina, or coronary artery disease
  • No uncontrolled cardiac arrhythmias
  • No myocardial infarction within the past 6 months
  • No uncontrolled hypertension
  • No history of cerebrovascular events
  • No clinically significant peripheral arterial disease
  • No other clinically significant cardiac disease

Pulmonary

  • No hemoptysis within the past 6 months

Immunologic

  • No history of allergy or hypersensitivity to bevacizumab, oxaliplatin, or gemcitabine
  • No hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • No known allergy to other platinum compounds
  • No ongoing or active infection

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 serious, non-healing wound, ulcer, or bone fracture
  • No pre-existing peripheral neuropathy > grade 1
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or prostate cancer with a Gleason score < 7
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled illness
  • No gastrointestinal bleeding within the past 6 months
  • No unresolved physical trauma within the past 4 weeks

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 months since prior immunotherapy or biologic therapy
  • No prior adjuvant bevacizumab
  • No concurrent immunotherapy
  • No concurrent colony-stimulating factors during the first course of study therapy

Chemotherapy

  • Recovered from prior chemotherapy
  • More than 4 months since prior adjuvant chemotherapy for completely resected disease
  • At least 4 months since prior chemoradiotherapy for locally advanced disease
  • More than 4 months since prior gemcitabine as a radiosensitizer or as maintenance therapy
  • No prior cytotoxic chemotherapy for metastatic disease
  • No prior adjuvant oxaliplatin
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Chemotherapy
  • More than 4 months since prior radiotherapy
  • No prior radiotherapy to > 25% of bone marrow
  • No prior radiotherapy to sole site of measurable disease unless there is radiologically confirmed progression of the irradiated tumor
  • No concurrent radiotherapy

Surgery

  • More than 4 weeks since prior major surgery or trauma and recovered
  • No concurrent surgery

Other

  • More than 2 weeks since prior and no concurrent thrombolytic agents

    • Anticoagulation therapy with warfarin or low molecular weight heparin is allowed provided the following criteria are met:

      • At least 2 weeks at a stable dose
      • INR 2-3
      • No active bleeding or pathologic condition that confers a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • No recent or concurrent participation in another study of experimental drugs
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00112528
CDR0000430845, NCCTG-N034A
Not Provided
Not Provided
North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: George P. Kim, MD Mayo Clinic
Investigator: Anthony J. Jaslowski, MD, FACP CCOP - St. Vincent Hospital Cancer Center, Green Bay
National Cancer Institute (NCI)
July 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP