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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193622

Enrollment

Registered

2005-09-19

Start date

2004-04-30

Completion date

2009-01-31

Last updated

2010-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Unknown Primary

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.

Detailed description

Upon determination of eligibility, patients will be receive: * Bevacizumab + Erlotinib

Interventions

DRUGBevacizumab

DRUGErlotinib

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
Overall response rate	—

Secondary

Measure	Time frame
Time to progression	—
Overall survival	—
Overall tolerability	—
Overall toxicity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026