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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Neoplasms, Unknown Primary

Treatments

Drug: Erlotinib

Drug: Bevacizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193622

AVF 2968s

SCRI UNKPRI 15

Details and patient eligibility

About

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.

Full description

Upon determination of eligibility, patients will be receive:

Bevacizumab + Erlotinib

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.