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

NCT00066677 | Terminated Phase 2 Results DMC

• 3 other identifiers: CDR0000316454P30CA006927FCCC-03003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; recurrent pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  4 months

Secondary Outcomes (3)

• Objective Response Rate

  56 days

• Overall Survival

  From date of registration until the date of death, assessed up to 5 years

• Number of Participants With Thromboembolic Events

  93 days

Study Arms (2)

rhuMAB-VEGF

EXPERIMENTAL

bevacizumab 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks until disease progression, unacceptable toxicity or patient preference.

Drug: rhuMAB-VEGF

rhuMAB-VEGF and Docetaxel

EXPERIMENTAL

rhuMAB-VEGF,bevacizumab: 10 mg/kg by intravenous infusion over 30-90 minutes once every 2 weeks docetaxel, Taxotere: 35 mg/m2 given intravenously over 1 hour on days 1, 8, and 15 of each 28 day cycle. Treatment continued until evidence of disease progression, unacceptable toxicity, or patient preference.

Drug: rhuMAB-VEGF; Drug: docetaxel

Interventions

rhuMAB-VEGF DRUG

rhuMAB-VEGF; rhuMAB-VEGF and Docetaxel

docetaxel DRUG

rhuMAB-VEGF and Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Related Publications (1)

• 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.

  PMID: 20458210 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

The study was stopped according to the early stopping rule for futility.

Results Point of Contact

• Title: Steven J. Cohen
• Organization: Fox Chase Cancer Center

s_cohen@fccc.edu

215-728-2450

Study Officials

• Steven J. Cohen, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2003
• First Posted: August 7, 2003
• Study Start: October 1, 2003
• Primary Completion: November 1, 2008
• Study Completion: April 1, 2009
• Last Updated: March 5, 2021
• Results First Posted: March 5, 2021

Record last verified: 2021-02

Locations

US (1)