Treatment Based on Molecular Profiling Diagnosis Carcinoma of Unknown Primary Site

Carcinoma Clinical Trial

Official title: A Phase II Study of Chemotherapy Treatment Based on Molecular Profiling Diagnosis for Patients With Carcinoma of Unknown Primary Site

Status Active, not recruiting

Clinical Trial Summary

This is a non-randomized Phase II study. Patients determined at initial diagnosis to have a carcinoma of unknown primary site will have their treatment selected with the use of a molecular profiling assay. A molecular profiling 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.

Clinical Trial Description

Patients in all subgroups will be evaluated for response to treatment after completing 2 cycles. Standard, disease specific, restaging methods will be employed. Patients with objective response or stable disease will continue treatment, with subsequent re-evaluations after every 2 cycles of therapy. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Neoplasms, Unknown Primary

• NCT number: NCT00737243
• Study type: Interventional
• Source: SCRI Development Innovations, LLC
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 2008
• Completion date: September 2015