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Treatment Based on Molecular Profiling Diagnosis Carcinoma of Unknown Primary Site

NCT00737243 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2016-08-17

Study results available
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Summary

This is a non-randomized Phase II study. Patients determined at initial diagnosis to have a carcinoma of unknown primary site (CUP) will have their treatment selected with the use of a molecular profiling assay. The assay will be performed on paraffin-embedded tumor tissue from a biopsy specimen. Patients given specific diagnoses (e.g., lung, pancreas, colon, breast, renal cell, prostate and ovarian cancer) will receive treatment regimens of proven activity. If no specific diagnosis is made with the molecular profiling assay, empiric chemotherapy with paclitaxel, carboplatin, bevacizumab and erlotinib will be administered.

Conditions

  • Carcinoma

Interventions

DRUG

Paclitaxel

175 mg/m2, 1-3 hour IV infusion Day 1

DRUG

Carboplatin

AUC 6.0 IV Day 1

DRUG

Bevacizumab

15 mg/kg IV infusion Day 1

DRUG

Erlotinib

150 mg PO

OTHER

Treatment determined by physician

Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • John D Hainsworth, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-11-30
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00737243 on ClinicalTrials.gov