Maximum Tolerated Dose of Lapatinib When Given With Carbo... | NCT00317434

Studies
Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer

NCT00317434

Sponsor

University of Alabama at Birmingham

Status

Terminated

Last Update Posted

Dec 15, 2009Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Ovarian Cancer

Interventions

lapatinib

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
104239

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.

Expanded Access Info

Not provided

Start Date

Nov 2005

Primary Completion Date

Mar 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Apr 20, 2006

First Submission Date that Met QC Criteria

Apr 20, 2006

First Posted Date

Apr 24, 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

Dec 10, 2009

Last Update Posted Date

Dec 15, 2009Estimated

Name	Class
GlaxoSmithKline	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine the maximum tolerated dose of Lapatinib with Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with carboplatin AUC 6 in this cohort of patients.

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Name	Type	Description	Arm Group Labels	Other Names
lapatinib	Drug

Measure	Description	Time Frame
MTD of Lapatinib measured in cohorts of 3-6 patients each

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologic diagnosis of epithelial ovarian or primary peritoneal cancer
Measurable disease or evaluable disease with CA125 >100
One prior treatment with taxane/platinum based chemotherapy, but patients with recurrent ovarian cancer not receiving platinum-based chemotherapy at time of initial diagnosis will be allowed
Recurrence after treatment free interval of at least 6 mos from completion of primary chemotherapy
19 years of age or older
Life expectancy of greater than 12 weeks
Performance status of 0, 1 or 2 (based on GOG Performance Status)
Normal bone marrow, renal and hepatic function based upon lab tests
Cardiac ejection fraction within institutional normal range
Ability to swallow and retain oral medication
Ability to understand a written informed consent document

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering study
Epithelial ovarian tumors of low malignant potential, stromal or germ cell origin
Non-measurable or non-evaluable disease
Archived tumor tissue not available for assay
Patients may not be receiving any other investigational agents or concurrent anticancer therapy, or herbal (alternative) medicines
Patients with known brain metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
Uncontrolled inter-current illness
Patients who are pregnant
HIV-positive patients receiving combination anti-retroviral therapy
Patients with GI tract disease resulting in an inability to take oral medication

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ronald D. Alvarez, MD	University of Alabama at Birmingham	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35205	United States
Indiana University School of Medicine

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18692224	Result	Kimball KJ, Numnum TM, Kirby TO, Zamboni WC, Estes JM, Barnes MN, Matei DE, Koch KM, Alvarez RD. A phase I study of lapatinib in combination with carboplatin in women with platinum sensitive recurrent ovarian carcinoma. Gynecol Oncol. 2008 Oct;111(1):95-101. doi: 10.1016/j.ygyno.2008.07.001. Epub 2008 Aug 8.

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Measure	Description	Time Frame
Clinical response rate defined by RECIST and CA125 values
EGRF, ErbB-2, PTEN and K-ras expression in tissue samples
Correlate serum levels of Lapatinib with AE's & efficacy