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A Phase I/II Study of Fixed-Dose Rate Gemcitabine and Bevacizumab for Postoperative Adjuvant Treatment of Patients With Resected Pancreatic Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

A Phase I/II Study of Fixed-Dose Rate Gemcitabine and Bevacizumab for Postoperative Adjuvant Treatment of Patients With Resected Pancreatic Cancer


OBJECTIVES:

Primary

- Determine the safety of adjuvant, fixed-dose rate gemcitabine hydrochloride and
bevacizumab in patients with completely resected pancreatic cancer.

- Determine the 1-year disease-free survival rate in patients treated with this regimen.

Secondary

- Determine the 1- and 2-year overall survival rates in these patients.

- Determine the median disease-free survival rate in these patients.

- Determine the median overall survival rate in these patients.

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

Patients receive gemcitabine hydrochloride IV over 100 minutes followed by bevacizumab* IV
over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in
the absence of disease recurrence or unacceptable toxicity.

NOTE: *The first dose of bevacizumab is not administered until after 6 weeks have passed
since surgery.

After completion of study therapy, patients are followed periodically for 18 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed adenocarcinoma of the pancreas

- Completely resected disease

- Underwent 1 of the following procedures 3-8 weeks ago:

- Standard pancreaticoduodenectomy (for tumors of the pancreatic head)

- Distal pancreatectomy (for tumors of the pancreatic tail)

- No grossly positive surgical margins

- Positive microscopic margins allowed

- Nonmeasurable disease

- No known CNS disease

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 6 months after
completion of study therapy

- CA 19-9 ≤ 2.5 times upper limit of normal (ULN)

- Absolute neutrophil count ≥ 1,500/mm³

- Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)

- Platelet count ≥ 100,000/mm³

- INR ≤ 1.5 (except in patients receiving full-dose warfarin)

- Bilirubin ≤ 2.0 mg/dL

- AST and ALT ≤ 2.5 times ULN

- Creatinine ≤ 2.0 mg/dL

- No clinically significant impairment of renal function

- No postoperative complications, including any of the following:

- Wound dehiscence or infection

- Intra-abdominal abscess

- Pancreatic or biliary leak or fistula

- Grade 3 or 4 delayed hemorrhage (occurring > 5 days postoperatively)

- Bowel perforation

- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abcess within
the past 6 months

- No history of major psychiatric disorder or other chronic medical illness that, in
the opinion of the treating physician, contraindicates use of the study drugs or
renders the patient at high risk of treatment-related complications

- No other cancer within the past 5 years except basal cell or squamous cell skin
cancer

- No history of serious systemic disease, including any of the following:

- Myocardial infarction or unstable angina within the past 12 months

- New York Heart Association class II-IV congestive heart failure

- Unstable symptomatic arrhythmia requiring medication

- Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal
supraventricular tachycardia) allowed

- No history of stroke or transient ischemic attack

- No symptomatic peripheral vascular disease

- No significant vascular disease (e.g., aortic aneurysm, aortic dissection)

- No inadequately controlled hypertension (i.e., blood pressure > 150/100 mm Hg on
antihypertensive medication)

- No prior hypertensive crisis or hypertensive encephalopathy

- No proteinuria (defined as urine protein:creatinine ratio ≥ 1.0 OR proteinuria ≥ 2+
by dipstick urinalysis OR protein > 1 g by 24-hour urine collection)

- No serious, nonhealing wound or ulcer

- No evidence of bleeding diathesis or coagulopathy

- No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy or radiotherapy for pancreatic cancer

- No prior systemic or investigational therapy for pancreatic cancer

- No major surgical procedure (except for resection of pancreatic cancer) or open
biopsy within the past 28 days

- No fine-needle aspiration or core biopsy within the past 7 days

- No anticipated need for a major surgical procedure during study treatment

- No concurrent newly prescribed nonsteroidal anti-inflammatory drugs (NSAIDs)

- Concurrent chronic-dose NSAIDs for analgesia are allowed

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety of gemcitabine when administered with bevacizumab as assessed by NCI CTCAE v3.0

Safety Issue:

Yes

Principal Investigator

Andrew Ko, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000517330

NCT ID:

NCT00410774

Start Date:

July 2006

Completion Date:

October 2007

Related Keywords:

  • Pancreatic Cancer
  • stage III pancreatic cancer
  • stage I pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage II pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115