Weekly Topotecan With Docetaxel in Recurrent Small Cell L... | NCT00315211

Studies
Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer

NCT00315211

Sponsor

Aultman Health Foundation

Status

Terminated

Last Update Posted

Aug 20, 2018Actual

Enrollment

7Actual

Phase

Phase 2

Conditions

Mediastinal Neoplasms

Interventions

Intravenous Topotecan
Intravenous Docetaxel

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Lung 01	Other Identifier	Aultman Health Foundation

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow Accrual

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Jun 2007Actual

Completion Date

Nov 8, 2007Actual

First Submitted Date

Apr 17, 2006

First Submission Date that Met QC Criteria

Apr 17, 2006

First Posted Date

Apr 18, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2018

Last Update Posted Date

Aug 20, 2018Actual

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

Brief Summary

The purposes of this study are:

To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
To determine the feasibility and toxicity of the combination of topotecan and docetaxel.

Detailed Description

The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.

Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Other	Weekly intravenous topotecan with intravenous docetaxel	Drug: Intravenous Topotecan Drug: Intravenous Docetaxel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous Topotecan	Drug	Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days	Arm A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel	To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recurred greater than 90 days after initial treatment
At least 1 measurable lesion
Only 1 prior chemotherapy
Must be over 18 years of age
ECOG performance status of 0 - 2
Adequate hematologic, renal, and hepatic function

Exclusion Criteria:

No prior use of topotecan, docetaxel, or irinotecan
No symptomatic brain metastases
History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
No prior investigational agents within 1 month prior
Lung cancer of mixed histology
Known uncontrolled seizure disorders

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raza Khan, MD	Aultman Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aultman Hospital		Canton	Ohio	44710	United States

Condition Browse Module

MeSH Terms

ID	Term
D008479	Mediastinal Neoplasms

Ancestor Terms

ID	Term
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008477	Mediastinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019772	Topotecan
D000077143	Docetaxel

Ancestor Terms

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds
D043823	Taxoids

Browse Leaves

Not provided

Browse Branches

Not provided