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TerminatedNCT00317434Updated Dec 15, 2009

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

A Phase 1 interventional study of lapatinib in Ovarian Cancer, sponsored by University of Alabama at Birmingham. Terminated at 2 sites in United States. Open to female participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2009-12-15.

Sponsored by University of Alabama at Birmingham · Phase 1, Interventional, and Treatment

Why this study was terminated
Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Non-randomized
Ages
19 Years to 90 Years
Sex
Female
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Study 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.

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Conditions studied

  • Ovarian Cancer

Keywords

  • ovarian cancer
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In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 12 is below the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 90 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Interventions

  • Druglapatinib
06

What researchers measure

Primary outcomes

  1. MTD of Lapatinib measured in cohorts of 3-6 patients each

Secondary outcomes

  1. Clinical response rate defined by RECIST and CA125 values

  2. EGRF, ErbB-2, PTEN and K-ras expression in tissue samples

  3. Correlate serum levels of Lapatinib with AE's & efficacy

07

Study locations

2 sites
  • University of Alabama at Birmingham
    Birmingham, Alabama 35205, United States
  • Indiana University School of Medicine
    Indianapolis, Indiana 48202, United States
08

References and documents

Publications

  • 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. PubMed 18692224 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00317434
Lead sponsor
University of Alabama at Birmingham
Collaborators
GlaxoSmithKline
First posted
Apr 24, 2006
Start date
Nov 2005
Primary completion
Mar 2007
Completion
Apr 2007
Last update
Dec 15, 2009

Study contacts

Ronald D. Alvarez, MD
principal investigator · University of Alabama at Birmingham
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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