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

NCT ID: NCT00317434

Last Updated: 2009-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-04-30

Brief Summary

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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

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Conditions

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Ovarian Cancer

Keywords

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ovarian cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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lapatinib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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University of Alabama at Birmingham

Principal Investigators

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Ronald D. Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Indiana University School of Medicine

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18692224 (View on PubMed)

Other Identifiers

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104239

Identifier Type: -

Identifier Source: secondary_id

UAB 0538 - F051025014

Identifier Type: -

Identifier Source: org_study_id