Clinical trial · Interventional
Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer
A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lapatinib | Drug | Lapatinib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- MTD of Lapatinib measured in cohorts of 3-6 patients each
Secondary outcomes (3)
- measure
- Clinical response rate defined by RECIST and CA125 values
- measure
- EGRF, ErbB-2, PTEN and K-ras expression in tissue samples
- measure
- Correlate serum levels of Lapatinib with AE's & efficacy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTKimball 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 18692224