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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2009-01-31

Brief Summary

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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

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Upon determination of eligibility, patients will be receive:

* Bevacizumab + Erlotinib

Conditions

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Neoplasms, Unknown Primary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bevacizumab

Intervention Type DRUG

Erlotinib

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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John D. Hainsworth, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

References

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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.

Reference Type RESULT

PMID: 17470864 (View on PubMed)

Other Identifiers

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AVF 2968s

Identifier Type: -

Identifier Source: secondary_id

SCRI UNKPRI 15