Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

NCT00193622 | Completed Phase 2

• 2 other identifiers: SCRI UNKPRI 15AVF 2968s
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial will investigate the combination of bevacizumab, and erlotinib in patients with adenocarcinoma or poorly differentiated carcinoma of unknown primary site. Bevacizumab and erlotinib are relatively well-tolerated and have non-overlapping toxicity profiles. This trial will be one of the first clinical trials to evaluate a combination of targeted agents in the treatment of a solid tumor.

Conditions

Neoplasms, Unknown Primary

Outcome Measures

Primary Outcomes (1)

• Overall response rate

Secondary Outcomes (4)

• Time to progression

• Overall survival

• Overall tolerability

• Overall toxicity

Interventions

Bevacizumab DRUG

Erlotinib DRUG

Eligibility Criteria

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

You may qualify if:

• To be included in this study, you must meet the following criteria:
• Carcinoma of unknown primary site confirmed by biopsy
• Measurable disease
• ECOG performance status must be 0-1
• Adequate bone marrow, liver and kidney
• Understand the nature of this study and give written informed consent.

You may not qualify if:

• You cannot participate in this study if any of the following apply to you:
• Age\< 18 years
• May not have received EGFR inhibitors
• History of acute myocardial infarction within 6 months
• Clinically significant cardiovascular disease
• Moderate to severe peripheral vascular disease.
• History of stroke within 6 months
• History of abdominal fistula, perforation, or abscess within 6 months
• Active concurrent infections
• Serious underlying medical conditions
• Active brain metastases
• Women who are pregnant or lactating.
• PEG or G-tube
• Proteinuria
• Any nonhealing wound, ulcer, or bone fracture.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Genentech, Inc.: collaborator

Related Publications (1)

• Hainsworth JD, Spigel DR, Farley C, Thompson DS, Shipley DL, Greco FA; Minnie Pearl Cancer Research Network. Phase II trial of bevacizumab and erlotinib in carcinomas of unknown primary site: the Minnie Pearl Cancer Research Network. J Clin Oncol. 2007 May 1;25(13):1747-52. doi: 10.1200/JCO.2006.09.3047.

  PMID: 17470864 RESULT

Related Links

• Published article in the Journal of Clinical Oncology

MeSH Terms

Conditions

Neoplasms, Unknown Primary

Interventions

Bevacizumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Study Officials

• John D. Hainsworth, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2004
• Primary Completion: September 1, 2005
• Study Completion: January 1, 2009
• Last Updated: September 17, 2010

Record last verified: 2010-09