Conditions: Carcinoma
Keywords: Carcinoma of Unknown Primary Site Molecular profiling assay Bevacizumab Erlotinib Paclitaxel Carboplatin
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 289
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Paclitaxel, Carboplatin, Bevacizumab and Erlotinib arm 2: Other treatment determined by physician based on molecular profiling assay

Interventions: intervention 1: Paclitaxel intervention 2: Carboplatin intervention 3: Bevacizumab intervention 4: Erlotinib intervention 5: Treatment determined by physician
Intervention descriptions: intervention 1: 175 mg/m2, 1-3 hour IV infusion Day 1 intervention 2: AUC 6.0 IV Day 1 intervention 3: 15 mg/kg IV infusion Day 1 intervention 4: 150 mg PO intervention 5: Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy

Protocol document: