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Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer, Lung Cancer, Stage IIIA Non Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
S-3304
Chemo-irradiation
Sponsored by
Shionogi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring 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

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Cancer Institute
  • Lombardi Cancer Center
  • University of Kansas Cancer Center
  • VA Medical Center-East Orange (study available to veterans only)
  • The Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

S-3304 plus chemo-irradiation

Chemo-irradiation

Arm Description

The tolerable dose of S-3304 determined in the Phase 1 part of the study will be dosed BID along with a standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy

The standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 24, 2004
Last Updated
April 30, 2018
Sponsor
Shionogi
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1. Study Identification

Unique Protocol Identification Number
NCT00078390
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 2003 (Actual)
Primary Completion Date
September 28, 2006 (Actual)
Study Completion Date
October 26, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shionogi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
S-3304 plus chemo-irradiation
Arm Type
Experimental
Arm Description
The tolerable dose of S-3304 determined in the Phase 1 part of the study will be dosed BID along with a standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy
Arm Title
Chemo-irradiation
Arm Type
Active Comparator
Arm Description
The standard of care regimen of radiation and paclitaxel/carboplatin chemotherapy will be administered
Intervention Type
Drug
Intervention Name(s)
S-3304
Intervention Description
S-3304 will be administered at the tolerable dose BID along with chemo-irradiation
Intervention Type
Other
Intervention Name(s)
Chemo-irradiation
Intervention Description
Standard of care chemo-irradiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Scripps Cancer Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
VA Medical Center-East Orange (study available to veterans only)
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07108
Country
United States
Facility Name
The Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer

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