Clinical trial NCT00066677: Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Official title: Phase II and Coagulation Study of rhuMAb-VEGF With or Without Docetaxel in Patients With Previously Treated Metastatic Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
recurrent pancreatic cancer
stage IV pancreatic cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-08-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Progression-free Survival
timeFrame: 4 months
Secondary outcomes:
measure: Objective Response Rate
timeFrame: 56 days
measure: Overall Survival
timeFrame: From date of registration until the date of death, assessed up to 5 years
measure: Number of Participants With Thromboembolic Events
timeFrame: 93 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center - Philadelphia
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Steven J. Cohen, MD
role: STUDY_CHAIR
References:
citation: Astsaturov IA, Meropol NJ, Alpaugh RK, Burtness BA, Cheng JD, McLaughlin S, Rogatko A, Xu Z, Watson JC, Weiner LM, Cohen SJ. Phase II and coagulation cascade biomarker study of bevacizumab with or without docetaxel in patients with previously treated metastatic pancreatic adenocarcinoma. Am J Clin Oncol. 2011 Feb;34(1):70-5. doi: 10.1097/COC.0b013e3181d2734a.