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Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer


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

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Trial Information

Multicenter, Open Label, Phase II Clinical Study of Gemcitabine, Capecitabine and Avastin in Pancreatic Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

every 2-4 months for 1 year and then every 6 months for at least 5 years

Safety Issue:

No

Principal Investigator

Renuka Iyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000409556

NCT ID:

NCT00100815

Start Date:

August 2004

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • recurrent pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065