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

Condition(s) targeted: Non Small Cell Lung Cancer

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

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Nick Thatcher, MD, Principal Investigator, Affiliation: Christie Hospitals NHS trust

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.

Official title: A Phase I, Open Label Study to Assess the Safety and Tolerability of ZD6474 (ZACTIMA) in Combination With Vinorelbine (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.

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome: Establish safety and tolerability of ZACTIMA in combination with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Secondary outcome:

Pharmacokinetics of ZACTIMA, vinorelbine or gemcitabine, plus cisplatin when co-administered

Preliminary assessment of efficacy of ZACTIMA when co-administered with vinorelbine plus cisplatin or gemcitabine plus cisplatin

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Starting date: August 2006
Ending date: October 2007
Last updated: June 12, 2008