Bevacizumab and Erlotinib in Treating Patients With Metastatic Pancreatic Cancer That Did Not Respond to Previous Treatment With Gemcitabine

NCT00365144 | Completed Phase 2 Results DMC

• 3 other identifiers: 054511UCSF-054511UCSF-H12191-28233-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with metastatic pancreatic cancer that did not respond to previous treatment with gemcitabine.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Overall Survival Rate at 6 Months

  Number of participants alive at 6 months

  6 months

• Safety and Toxicity

  Treatment associated toxicities. Adverse event assessments were performed on day 1 of each treatment cycle and at the end of treatment; the longest duration of treatment was 7 cycles (x 3 weeks)

  21 weeks

Secondary Outcomes (3)

• Objective Response as Measured by RECIST Criteria

  21 weeks

• Time to Tumor Progression

  from initial therapy to the first objective documentation of tumor progression

• Proportion of Patients With ≥ 25% Decline in Serum CA19-9 Biomarker

  21 weeks

Study Arms (1)

Bevacizumab Plus Erlotinib Hydrochloride

EXPERIMENTAL

A treatment cycle is 21 days: bevacizumab 15 mg/kg as a 60-90 min infusion once every 21 days, with erlotinib hydrochloride 150 mg by mouth daily

Biological: bevacizumab; Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis

Interventions

bevacizumab BIOLOGICAL

Bevacizumab Plus Erlotinib Hydrochloride

erlotinib hydrochloride DRUG

Bevacizumab Plus Erlotinib Hydrochloride

laboratory biomarker analysis OTHER

Bevacizumab Plus Erlotinib Hydrochloride

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the pancreas * Documented extrapancreatic metastases * Radiographically measurable disease not required * Gemcitabine hydrochloride-refractory disease * Has undergone 1-3 prior therapies for locally advanced or metastatic disease with ≥ 1 regimen containing gemcitabine hydrochloride (alone or in combination with other agents) * Treatment given in the adjuvant setting (radiotherapy and/or chemotherapy, given either concurrently or systemically) does not count as prior therapy as long as progressive disease occurs \> 6 months after completion of treatment * No central nervous system (CNS) or brain metastases PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * International Normalized Ratio (INR) ≤ 1.5 (except in patients receiving full-dose warfarin) * Bilirubin ≤ 2.0 mg/dL * Creatinine ≤ 2.0 mg/dL * AST or ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if documented liver metastases) * Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed) * No contact lense use during and for 14 days after completion of study treatment * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment * No history of other disease, metabolic dysfunction, or physical examination or clinical laboratory finding that contraindicates use of an investigational drug or precludes study compliance * No history of serious systemic disease, including any of the following: * Myocardial infarction within the past 6 months * Stroke within the past 6 months * Uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg on medication) * Unstable angina * New York Heart Association class II-IV congestive heart failure * Unstable symptomatic arrhythmia requiring medication * Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed * Peripheral vascular disease ≥ grade 2 * No significant traumatic injury within the past 28 days * No proteinuria (defined as urine protein:creatinine ratio ≥ 1.0 at screening) * No clinically significant impairment of renal function * No serious, nonhealing wound, ulcer, or bone fracture * No evidence of bleeding diathesis or coagulopathy * No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months PRIOR CONCURRENT THERAPY: * More than 28 days since prior major surgery or open biopsy * More than 7 days since prior fine-needle aspiration or core biopsy * No prior antiangiogenesis agent (e.g., bevacizumab or an oral vascular endothelial growth factor receptor small molecule inhibitor) given together with an agent that disrupts epidermal growth factor receptor signaling (e.g., cetuximab or erlotinib hydrochloride) for locally advanced or metastatic pancreatic cancer * Prior treatment with either one of the above alone allowed * More than 4 weeks since prior and no concurrent participation in another clinical trial * No other concurrent antineoplastic or antitumor agents, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy * No concurrent major surgery * No other concurrent investigational agents

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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Related Publications (2)

• Ko AH, Venook AP, Bergsland EK, Kelley RK, Korn WM, Dito E, Schillinger B, Scott J, Hwang J, Tempero MA. A phase II study of bevacizumab plus erlotinib for gemcitabine-refractory metastatic pancreatic cancer. Cancer Chemother Pharmacol. 2010 Nov;66(6):1051-7. doi: 10.1007/s00280-010-1257-5. Epub 2010 Feb 4.

  PMID: 20130876 RESULT

• Ko AH, Dito E, Schillinger B, et al.: A phase II study of bevacizumab (BEV) and erlotinib (ERL) in patients with gemcitabine (GEM)-refractory metastatic adenocarcinoma of the pancreas (PanCa). [Abstract] American Society of Clinical Oncology 2007 Gastrointestinal Cancers Symposium, 19 -21 January 2007, Orlando, Florida A-187, 2007.

  RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Andrew Ko, MD
• Organization: UCaliforniaSF

andrewko@medicine.ucsf.edu

415-353-9888

Study Officials

• Andrew Ko, MD

  University of California, San Francisco

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: August 16, 2006
• First Posted: August 17, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2010
• Last Updated: January 19, 2018
• Results First Posted: November 25, 2013

Record last verified: 2017-12

Locations

US (1)