NCT00737243

Treatment Based on Molecular Profiling Diagnosis Carcinoma of Unknown Primary Site

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of the study is evaluate the impact of the molecular assay prediction on the efficacy of therapy for patients with carcinoma of unknown primary site (CUP). Investigators will use tumor profiling results to direct standard, site-specific first-line therapy for patients with CUP.

Conditions

• Carcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-11-01
• Completion: 2012-12-01
• First posted: 2008-08-18
• Last updated: 2016-08-17
• Results posted: 2016-08-17

Locations

21 sites across 1 country: United States