Phase I Combination With Vinorelbine or Gemcitabine Plus Cisplatin in Locally Advanced or Metastatic NSCLC

Genzyme

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Vinorelbine plus cisplatin; Drug: Zactima (ZD6474); Drug: Gemcitabine plus cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00496275

D4200C00054

Details and patient eligibility

About

To test the safety and tolerability of ZD6474 in combination withVinorelbine (Navelbine) or Gemcitabine (Gemzar) plus cisplatin as first line therapy in patients with locally advanced or metastatic (Stage IIIB-IV) Non Small Cell Lung Cancer.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed non small cell lung cancer (stage IIIB-IV)
• Life expectancy greater than 12 weeks
• At least 1 measurable lesion greater than 10mm in smallest diameter.

Exclusion criteria

• Prior treatment with anticancer agent
• Brain metastases
• Major surgery within last 4 weeks

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)