NCT00317434

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 ovarian-cancer

Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_1 ovarian-cancer

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

1.3 years

First QC Date

April 20, 2006

Last Update Submit

December 10, 2009

Conditions

Ovarian Cancer

Keywords

ovarian cancer

Outcome Measures

Primary Outcomes (1)

  • MTD of Lapatinib measured in cohorts of 3-6 patients each

Secondary Outcomes (3)

  • 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

Interventions

lapatinibDRUG

Eligibility Criteria

Age19 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 48202, United States

Location

Related Publications (1)

  • 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.

    PMID: 18692224RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Lapatinib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ronald D. Alvarez, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2006

First Posted

April 24, 2006

Study Start

November 1, 2005

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations

US(2)