Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	FCCC-03003 NCT00066677

Objectives

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

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

Outcomes

Progression-free survival

Objective response rate
Overall survival
Incidence of thromboembolic events

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.

Trial Contact Information

Trial Lead Organizations

Fox Chase Cancer Center - Philadelphia

Steven Cohen, MD, Protocol chair		Ph: 215-728-2450; 888-369-2427 Email: S_Cohen@fccc.edu

Registry Information
Official Title		Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients with Previously Treated Metastatic Pancreatic Adenocarcinoma
Trial Start Date		2003-10-15
Registered in ClinicalTrials.gov		NCT00066677
Date Submitted to PDQ		2003-06-27
Information Last Verified		2007-07-19
NCI Grant/Contract Number		CA06927

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