Gemcitabine/Irinotecan/ZD1839 vs Paclitaxel/Carboplatin/Etoposide/ZD1839 in Carcinoma of Unknown Primary Site

Conditions

• Neoplasms, Unknown Primary

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Etoposide — DRUG
  50 mg alternating with 100 mg PO, days 1 and 10 in regimen A
• Gemcitabine — DRUG
  1000 mg/m2 IV, days 1 and 8, in regimen B
• Irinotecan — DRUG
  1000 mg/m2 IV days 1 and 8 in regimen B
• Paclitaxel — DRUG
  200 mg/m2 by 1-hour IV infusion, day 1, regimen A
• Carboplatin — DRUG
  Area under the curve (AUC) 6.0 IV, day 1, regimen A

Study Details

In this randomized trial, we will investigate the activity and toxicity of two active regimens, gemcitabine/irinotecan and paclitaxel/carboplatin/Etoposide (both followed by ZD1839) in the first-line treatment of patients with carcinoma of unknown primary site.

Key Dates

Start date

Sep 30, 2003

Status verified

Mar 2013

Primary completion

Sep 30, 2008

Completion

Jun 30, 2009

Study Design

Enrollment

198 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Regimen A
  Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval
• Experimental: Regimen B
  Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval

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: 24 months ]

Locations (31)

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