Treatment Based on Molecular Profiling Diagnosis Carcinoma of Unknown Primary Site

Conditions

• Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Paclitaxel — DRUG
  175 mg/m2, 1-3 hour IV infusion Day 1
• Carboplatin — DRUG
  AUC 6.0 IV Day 1
• Bevacizumab — DRUG
  15 mg/kg IV infusion Day 1
• Erlotinib — DRUG
  150 mg PO
• Treatment determined by physician — OTHER
  Patients Assigned a Specific Diagnosis by the Molecular profiling Assay will have physician's choice therapy

Study Details

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.

Key Dates

First listed

Aug 18, 2008

Start date

Aug 31, 2008

Status verified

Jul 2016

Primary completion

Nov 30, 2012

Completion

Dec 31, 2012

Study Design

Enrollment

289 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
  Paclitaxel, Carboplatin, Bevacizumab and Erlotinib
• Other: Treatment determined by physician
  Other treatment determined by physician based on molecular profiling assay

Primary Outcome Measure

Overall Survival [ Time Frame: every 6-8 weeks (2 cycles) until death from any cause or lost to follow up, projected 18 months ]

Locations (21)

Find similar trials in Huntsville, AL

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