Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	NCCTG-N034A N034A, NCT00112528

Objectives

Primary

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

Secondary

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

Entry Criteria

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 6 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Survival at 6 months

Objective response rate as measured by RECIST criteria
Median survival
Progression-free survival
Time to treatment failure
Overall survival
Toxicity

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.

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

George Kim, MD, Protocol chair		Ph: 507-284-2511
Anthony Jaslowski, MD, FACP, Protocol co-chair		Ph: 920-884-3135 Email: tjaslowski@gboncology.com

Registry Information
Official Title		Phase II Trial of Bevacizumab, Gemcitabine, Oxaliplatin in Patients With Metastatic Pancreatic Adenocarcinoma of the Pancreas
Trial Start Date		2005-06-24
Trial Completion Date		2005-09-15 (estimated)
Registered in ClinicalTrials.gov		NCT00112528
Date Submitted to PDQ		2005-04-25
Information Last Verified		2006-07-15
NCI Grant/Contract Number		CA25224

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