Conditions: Neoplasms, Unknown Primary
Keywords: Neoplasms, Unknown Primary
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 198
Healthy volunteers: no

Brief summary:
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.

Detailed description:
Upon determination of eligibility, all patients will be randomly assigned to one of two treatment arms:

* Paclitaxel + Carboplatin + Etoposide
* Irinotecan + Gemcitabine

Patients will be stratified by tumor location (liver/bone versus all others) and number of metastatic sites (one versus two or more). Patients with an objective response or stable disease after completion of chemotherapy will receive ZD1839 until disease progression. Patients who do not respond to chemotherapy may crossover to the other chemotherapy regimen and will receive ZD1839 if they have an objective response or stable disease. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Arms:
arm 1: 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 arm 2: 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

Interventions: intervention 1: Etoposide intervention 2: Gemcitabine intervention 3: Irinotecan intervention 4: Paclitaxel intervention 5: Carboplatin
Intervention descriptions: intervention 1: 50 mg alternating with 100 mg PO, days 1 and 10 in regimen A intervention 2: 1000 mg/m2 IV, days 1 and 8, in regimen B intervention 3: 1000 mg/m2 IV days 1 and 8 in regimen B intervention 4: 200 mg/m2 by 1-hour IV infusion, day 1, regimen A intervention 5: Area under the curve (AUC) 6.0 IV, day 1, regimen A

Protocol document: