Paclitaxel/Carboplatin Plus Bevacizumab/Erlotinib in the First Line Treatment of Carcinoma of Unknown Primary Site

Conditions

• Neoplasm, Unknown Primary

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• paclitaxel — DRUG
  Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1
• carboplatin — DRUG
  Carboplatin AUC 6.0 IV Day 1
• bevacizumab — DRUG
  Bevacizumab 15mg/kg IV infusion,Day 1
• erlotinib — DRUG
  Erlotinib 150 mg by mouth daily

Study Details

We will evaluate the feasibility, toxicity, and effectiveness of combination chemotherapy (paclitaxel/carboplatin)plus combination targeted therapy (bevacizumab/erlotinib)in the first line treatment of patients with carcinoma of unknown primary site. There is limited experience with either bevacizumab or erlotinib in the treatment of cancers of unknown site but given the heterogeneous nature of the tumor, it is likely that inhibition of angiogenesis pathways and/or the EGFR pathway are effective strategies in at least a proportion.

Key Dates

First listed

Aug 4, 2006

Start date

Jul 31, 2006

Status verified

Nov 2013

Primary completion

Feb 29, 2008

Completion

Mar 31, 2009

Study Design

Enrollment

60 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Bevacizumab/Paclitaxel/Carboplatin/Erlotinib
  Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily

Primary Outcome Measure

Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death [ Time Frame: 18 months ]

Locations (9)

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