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

Neoplasms, Unknown Primary Clinical Trial

Official title:

A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193622
• Other study ID #: SCRI UNKPRI 15
• Secondary ID: AVF 2968s
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: September 15, 2010
• Start date: April 2004
• Est. completion date: January 2009

Study information

• Verified date: September 2010
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Upon determination of eligibility, patients will be receive:

• Bevacizumab + Erlotinib

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 2009
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

• Any clinical evidence or history of bleeding, clotting or coagulopathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Neoplasms, Unknown Primary

Intervention

Drug:
• Bevacizumab

• Erlotinib

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Genentech, Inc.

References & 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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Secondary	Time to progression
Secondary	Overall survival
Secondary	Overall tolerability
Secondary	Overall toxicity

External Links

•   Published article in the Journal of Clinical Oncology