Clinical trial NCT00078390: Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
Official title: A Phase I/II Study of the Safety, Pharmacokinetic Interaction and Efficacy of S-3304 in Combination With Standard Therapy in Patients With Locally Advanced Non-small Cell Lung Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non Small Cell Lung Cancer
Lung Cancer
Stage IIIA Non Small Cell Lung Cancer
Stage IIIB Non Small Cell Lung Cancer
Keywords: Lung cancer
Lung carcinoma
Non small cell lung cancer
Stage IIIA non small cell lung cancer
Stage IIIB non small cell lung cancer
NSCLC
Stage III
chemotherapy
radiation
chemoradiation
matrix metalloproteinases
neovascularization
antiangiogenesis
type IV collagenases
Unresectable locally advanced non-small cell lung cancer
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
First posted: 2004-02-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The Phase 1 part of the study will determine the tolerable dose of S-3304 in the presence of radiation and paclitaxel/carboplatin chemotherapy in a non-randomized manner.

The Phase 2 part will compare the effect combination of S-3304 in addition to chemo-irradiation therapy to the effect of radiation and paclitaxel/carboplatin chemotherapy alone on small cell lung tumors
Primary purpose: TREATMENT

Brief summary: A study to measure the safety and effectiveness of S-3304 when given in combination with conventional chemo-radiation therapy in patients with locally advanced non-small cell lung cancer.

Detailed description: A two part study to evaluate the safety and efficacy of S-3304 in combination with standard therapy in patients with locally advanced non-small cell lung cancer. The first part of the study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for further evaluation. The second part of the study is a randomized Phase II design to evaluate the efficacy of recommended S-3304 dose in combination with chemo-radiation.

Eligibility criteria: INCLUSION CRITERIA

* newly diagnosed non-small cell lung cancer of stage IIIA non-resectable or of stage IIIB without pleural effusion
* ECOG performance status 0-1
* adequate organ function
* clinically indicated and able to receive conventional chemoradiation therapy

EXCLUSION CRITERIA

* patients with prior history of cancer, other than basal cell carcinoma after appropriate treatment, or prior systemic chemotherapy treatment
* patients with other serious intercurrent illness including HIV/AIDS, or contraindicated for paclitaxel/carboplatin or thoracic irradiation treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Cancer Institute
state: California
city: Washington
country: United States
facility: Lombardi Cancer Center
state: District of Columbia
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: East Orange
country: United States
facility: VA Medical Center-East Orange (study available to veterans only)
state: New Jersey
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
References: