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Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma


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

Thank you

Trial Information

Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Steven J. Cohen, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000316454

NCT ID:

NCT00066677

Start Date:

October 2003

Completion Date:

April 2009

Related Keywords:

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

Name

Location

Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497