Paclitaxel and Carboplatin Combination as 1st Line Treatm... | NCT00750386

Studies
Paclitaxel and Carboplatin Combination as 1st Line Treatment in Ovarian Carcinomas

NCT00750386

Sponsor

Hellenic Oncology Research Group

Status

Completed

Last Update Posted

May 23, 2011Estimated

Enrollment

50Estimated

Phase

Phase 1Phase 2

Conditions

Ovarian Cancer

Interventions

Paclitaxel
Carboplatin

Countries

Greece

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

Status Module

Record Verification Date

May 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Sep 9, 2008

First Submission Date that Met QC Criteria

Sep 9, 2008

First Posted Date

Sep 10, 2008Estimated

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

May 20, 2011

Last Update Posted Date

May 23, 2011Estimated

Name	Class
University Hospital of Crete	OTHER

Description Module

Brief Summary

This trial will determine the feasibility and toxicity of dose intense (every 2 weeks) of paclitaxel+carboplatin combination following cytoreductive surgery in patients with stage Ic-IV ovarian cancer.

Detailed Description

Dose dense chemotherapy has been proven beneficial in various oncological settings. It is proposed that this concept be tested in ovarian cancer, with the support of growth factors. It is hypothesized that, if feasible, dose-dense chemotherapy may be more effective.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Paclitaxel/Carboplatin	Drug: Paclitaxel Drug: Carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Paclitaxel	Drug	175 mg/m2, I.V, every 2 weeks	1
Carboplatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Determine the maximum tolerated dose and the response rate		Toxicity assestment of the 1st cycle for the first 10 patients. Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)

Secondary Outcomes

Measure	Description	Time Frame
Toxicity profile		Toxicity assessment on each cycle
Time to tumor progression		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically- or cytologically- confirmed ovarian cancer requiring standard chemotherapy
Patients have to be chemotherapy naive
Patients may have undergone cytoreductive surgery, or this may have been omitted due to dissemination
Age >18 years.
Performance status (WHO) 0-2
Life expectancy of at least three months.
Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3).
Adequate liver (Bilirubin<1.5 times upper limit of normal and SGOT/SGPT<2 times upper limit of normal) and renal function (creatinine<2mg/dl)
Informed consent

Exclusion Criteria:

Pregnant or nursing
Psychiatric illness or social situation that would preclude study compliance'
Other concurrent uncontrolled illness
No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christos Emmanouilides, MD	Interbalkan Hospital, division of Oncology, Pylaia, Thessaloniki	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Crete		Heraklion	Crete	71110	Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms
D009369	Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D010049	Ovarian Diseases
D000291	Adnexal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017239	Paclitaxel
D016190	Carboplatin

Ancestor Terms

ID	Term
D043823	Taxoids
D043822	Cyclodecanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic

Browse Leaves

Not provided

Browse Branches

Not provided