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A Phase II Study Designed to Evaluate the Safety and Efficacy of the Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Early Relapse Patients (< 6 Months) With Ovarian Cancer, Overexpressing HER2, Previously Treated With Carboplatin-Paclitaxel


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

A Phase II Study Designed to Evaluate the Safety and Efficacy of the Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Early Relapse Patients (< 6 Months) With Ovarian Cancer, Overexpressing HER2, Previously Treated With Carboplatin-Paclitaxel


Inclusion Criteria:



- 18 years or older; patients with histologically proven diagnosis of ovarian cancer.

- Patients with metastatic disease and an overexpression of HER2 (as determined by
immunochemistry)

- Patients who have progressed while receiving treatment, or within 6 months after
completion of treatment. Patients must have received carboplatin and paclitaxel.

- Patients who have received at minimum one line of chemotherapy

- 3 weeks minimum since last treatment with chemotherapy must have elapsed

- Patients must have at least 1 measurable lesion per Response Evaluation Criteria in
Solid Tumors (RECIST) or an assessable cancer antigen (CA) 125 > 1.25 x upper limit
of normal (ULN)

- Patients must have ECOG of 2 or less

- Left ventricular ejection fraction (LVEF) of 50% or better

- Patients have given their signed and verbal consent

Exclusion Criteria:

- Previous treatment with Herceptin or similar products affected growth factors (eg:
Iressa)

- Another experimental treatment in the previous 30 days

- No overexpression of HER2 receptors

- Patients having received high-dose chemotherapy or stem-cell interventions

- Other cancers within the last 5 years

- Patients with dyspnea at rest or requiring oxygen therapy

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Eric Pujade-Lauraine, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital Hotel-Dieu

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TCHERCEPTIN1

NCT ID:

NCT00189579

Start Date:

Completion Date:

January 2007

Related Keywords:

  • Ovarian Cancer
  • HERCEPTIN
  • Carboplatin
  • Paclitaxel
  • Relapse
  • Ovarian Neoplasms

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