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Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
This study has been completed.
First Received: August 6, 2003   Last Updated: August 29, 2009   History of Changes
Sponsors and Collaborators: Fox Chase Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00066677
  Purpose

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bevacizumab with docetaxel may kill more tumor cells.

PURPOSE: This randomized phase II trial is studying bevacizumab and docetaxel to see how well they work compared to bevacizumab alone in treating patients with metastatic pancreatic cancer.


Condition Intervention Phase
Pancreatic Cancer
Biological: bevacizumab
Drug: docetaxel
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Incidence of thromboembolic events [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: October 2003
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the progression-free survival of patients with previously treated metastatic pancreatic adenocarcinoma treated with bevacizumab with or without docetaxel.
  • Determine the objective response rate and overall survival of patients treated with these regimens.
  • Determine the incidence of thromboembolic events in patients treated with these regimens.

OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and docetaxel IV over 1 hour on days 1, 8, and 15.
  • Arm II: Patients receive bevacizumab as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the pancreas

    • Metastatic disease
  • Unidimensionally measurable disease outside of the pancreas

    • At least 1 lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Must have received 1, and only 1, prior gemcitabine-containing regimen for metastatic disease unless disease has recurred within 6 months after treatment with neoadjuvant or adjuvant gemcitabine-containing therapy
  • No brain metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9.0 g/dL (transfusion allowed)
  • No bleeding diathesis or coagulopathy

Hepatic

  • Bilirubin no greater than upper limit of normal (ULN)
  • AST and ALT no greater than 1.5 times ULN
  • INR no greater than ULN
  • PTT no greater than ULN

Renal

  • Creatinine no greater than 2.0 mg/dL
  • No clinically significant renal impairment
  • Urine protein:creatinine ratio ≥ 1.0

Cardiovascular

  • No prior myocardial infarction
  • No prior stroke
  • No clinically significant cardiovascular disease
  • No uncontrolled hypertension (i.e., blood pressure greater than 160/110 mm Hg on medication)
  • No unstable angina
  • No New York Heart Association class II-IV congestive heart failure
  • No serious cardiac dysrhythmia requiring medication
  • No peripheral vascular disease

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history or evidence of CNS disease (e.g, primary brain tumor or seizures not controlled with standard medical therapy)
  • No other medical condition that would preclude study participation
  • No psychiatric condition that would preclude study participation
  • No other prior or concurrent malignancy that would preclude study participation
  • No significant traumatic injury within the past 28 days
  • No serious, nonhealing wound, ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic granulocyte or platelet growth factors

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • At least 4 weeks since prior radiotherapy

Surgery

  • More than 7 days since prior fine needle aspirations or core biopsies
  • More than 28 days since prior surgery (except closed biopsy or access port placement)
  • More than 28 days since prior open biopsy
  • No concurrent surgery

Other

  • More than 4 weeks since prior experimental drug study participation
  • More than 4 weeks since prior investigational drugs
  • No other concurrent experimental drug study participation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00066677

Locations
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators
Fox Chase Cancer Center
Investigators
Study Chair: Steven J. Cohen, MD Fox Chase Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000316454, FCCC-03003
Study First Received: August 6, 2003
Last Updated: August 29, 2009
ClinicalTrials.gov Identifier: NCT00066677     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Pancrelipase
Recurrence
Docetaxel
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Adenocarcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Antineoplastic Agents
Growth Substances
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Pharmacologic Actions
Docetaxel
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Pancreatic Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009