A Study of Fixed-Dose Rate Gemcitabine, Cisplatin, and Bevacizumab in Previously Untreated Patients With Metastatic Pancreatic Cancer
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Study of Fixed-Dose Rate Gemcitabine, Cisplatin, and Bevacizumab in Previously Untreated Patients With Metastatic Pancreatic Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression
Safety Issue:
No
Principal Investigator
Andrew Ko, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, San Francisco
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000437858
NCT ID:
NCT00126633
Start Date:
April 2004
Completion Date:
October 2008
Related Keywords:
- Pancreatic Cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
Name | Location |
|---|---|
| UCSF Comprehensive Cancer Center | San Francisco, California 94115 |
