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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Epithelial Cancer Stage III, Stage IV Ovarian Cancer, Stage IV Breast Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Saul Rivkin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Swedish Medical Center Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CRC 0503

NCT ID:

NCT00316407

Start Date:

August 2005

Completion Date:

November 2009

Related Keywords:

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

Name

Location

University of New Mexico Cancer CenterAlbuquerque, New Mexico  87131-5636
Swedish Medical Center Cancer InstituteSeattle, Washington  98104