Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients

Stage IV Breast Cancer Clinical Trial

Official title:

Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00316407
• Other study ID #: CRC 0503
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 18, 2006
• Last updated: February 16, 2011
• Start date: August 2005
• Est. completion date: November 2009

Study information

• Verified date: March 2010
• Source: Swedish Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.

Description:

The MTD was found in the phase I portion of this study to be oral lapatinib 1000 mg per day for each 4 week cycle and paclitaxel 60 mg/m2 weekly x 3 of a 4 week cycle and carboplatin AUC 2 weekly x 3 of a 4 week cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients.

• Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease.

• Ability to swallow and retain oral medications.

• Measurable disease

Exclusion Criteria:

• Treatment with previous weekly carboplatin and paclitaxel.

• No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab.

• No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Neoplasms, Glandular and Epithelial
• Ovarian Epithelial Cancer Stage III
• Ovarian Neoplasms
• Stage IV Breast Cancer
• Stage IV Ovarian Cancer

Intervention

Drug:
• lapatinib (GW572016)
1000 mg po qd
• Carboplatin
AUC 2 weekly x 3 of 4 week cycle
• Paclitaxel
60 mg/m2 weekly x 3 of 4 week cycle

Locations

Country	Name	City	State
United States	University of New Mexico Cancer Center	Albuquerque	New Mexico
United States	Swedish Medical Center Cancer Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Swedish Medical Center	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity		1 year	Yes
Secondary	Objective response (PR or CR)		1 year	No