A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.

Condition(s) targeted: Carcinoma, Non-Small-Cell Lung

Intervention: docetaxel (Drug); CP-868,596 + docetaxel (Drug); AG-013736 + docetaxel (Drug); CP-868,596 + AG-013736 + docetaxel (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

To determine the effectiveness of CP-868,596 + docetaxel, AG-013736 + docetaxel and CP-868,596 + AG-013736 + docetaxel in patients previously treated for non-small cell lung cancer.

Official title: Phase 2 Study of CP-868,596 + Docetaxel, AG-013736 + Docetaxel, or CP-868,596 + AG-013736 + Docetaxel and of Docetaxel Alone in Patients With Stage IIIb or IV Non-Small Cell Lung Cancer.

Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Determine the anti-tumor efficacy of CP 868,596 plus docetaxel, AG 013736 plus docetaxel, CP 868,596 plus AG 013736 plus docetaxel, and docetaxel alone in patients with advanced NSCLC based on objective tumor response (CR and PR) rate

Secondary outcome:

Determine the safety and tolerability of the combination of daily CP 868,596 and docetaxel on an every 3 week schedule

Determine the safety and tolerability of the combination of daily AG 013736 and docetaxel on an every 3 week schedule

Determine the safety and tolerability of both CP 868,596 and AG 013736 given together with docetaxel on an every 3 week schedule

Assess additional evidence of anti-tumor activity as measured by duration of objective response, progression-free survival, and one-year survival (OS1year)

Evaluate the pharmacokinetics (PK) of AG 013736 and CP 868,596 when given together with and without docetaxel

Evaluate the PK of CP 868,596 when given in combination with docetaxel

Evaluate the PK of docetaxel when given in combination with CP 868,596, or CP 868,596 plus AG 01373

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

Criteria:

Inclusion Criteria:

- Platinum-pretreated patients with advanced stage IIIb or IV NSCLC

Exclusion Criteria:

- Centrally-located tumors

To obtain contact information for a study center near you, click here.

Starting date: May 2007
Last updated: June 6, 2007