Clinical trial NCT00193622: Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site
Official title: A Phase II Trial of Bevacizumab and Erlotinib in the Treatment of Patients With Carcinoma of Unknown Primary Site
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neoplasms, Unknown Primary
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2005-09-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rate
Secondary outcomes:
measure: Time to progression
measure: Overall survival
measure: Overall tolerability
measure: Overall toxicity
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.