Clinical trial NCT00317434: Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer
Official title: A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ovarian Cancer
Keywords: ovarian cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2006-04-24
Enrollment: 12
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: MTD of Lapatinib measured in cohorts of 3-6 patients each
Secondary outcomes:
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
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: University of Alabama at Birmingham
name: Ronald D. Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.