Efficacy Study of Weekly Taxotere and Topotecan for Recurrent Gynecologic (GYN) Cancers

This study has been completed.
Sponsor:
Collaborators:
Sanofi
GlaxoSmithKline
Information provided by (Responsible Party):
Mark H. Einstein, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00231855
First received: September 30, 2005
Last updated: April 22, 2012
Last verified: April 2012
  Purpose

The primary aim of this study is:

  • To determine the overall clinical response rate of weekly Topotecan and Taxotere in women with recurrent ovarian, primary peritoneal, endometrial and uterine cancers.

The secondary aims of this study are:

  • To evaluate the safety and tolerability of the combination therapy with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial or uterine cancers.
  • To determine the progression free survival and overall survival in women treated with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial and uterine cancers who have been previously treated with chemotherapy and/or radiation therapy.

Condition Intervention Phase
Ovarian Neoplasms
Uterine Neoplasms
Drug: Topotecan and Taxotere
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial- Weekly Taxotere and Topotecan for Recurrent Ovarian, Primary Peritoneal, Endometrial and Uterine Cancers

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • To determine the overall clinical response rate of weekly Topotecan and Taxotere in women with recurrent ovarian, primary peritoneal, endometrial and uterine cancers

Secondary Outcome Measures:
  • To evaluate the safety and tolerability of weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial or uterine cancers
  • To determine the progression free survival and overall survival with weekly Topotecan and Taxotere in patients with recurrent ovarian, primary peritoneal, endometrial and uterine cancers who have been previously treated with chemotherapy

Estimated Enrollment: 31
Study Start Date: November 2004
Study Completion Date: March 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically documented recurrent endometrial adenocarcinoma, papillary serous (UPSC), or mixed mullerian tumor (MMT) for which a cure or substantial palliation is unlikely using surgery and/or radiotherapy. Patients must have measurable disease or disease felt to be reproducibly measurable on CT scan, chest x-ray and/or tumor marker elevations .
  • Recurrent ovarian or primary peritoneal cancers as defined as either:

    1. Measurable disease either by physical examination or by imaging or
    2. Non-measurable evidence of disease such as any or all of the following standard Rustin criteria:

      1. Peritoneal implants <2 cm
      2. Abnormal densities on computerized tomography (CT) scan and/or loculated fluid collections
      3. Elevated CA-125 (>100 U/mL on 2 measurements at least 1 week apart) and disease- related symptoms.
  • Patients with the following histologic ovarian or uterine epithelial cell types are eligible:

    • Serous adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mucinous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell
    • Malignant Brenner's tumor
    • Adenocarcinoma NOS
  • Age ≥ 18 years.
  • ECOG performance status of ≤ 2.
  • Peripheral neuropathy must be ≤ grade 1
  • Previously treated patients must have received no antineoplastic treatment for at least 4 weeks. Patients will not have received more than two previous chemotherapy regimens.
  • In patients previously irradiated, the recurrent disease should be outside of the radiotherapy portal or have developed disease progression within the radiated field.
  • No concurrent chemotherapy, radiotherapy, immunotherapy, or hormone therapy.
  • Hepatic:

    • Total bilirubin ≤ ULN
    • AST and ALT and alkaline phosphatase must be within the range allowing for eligibility.
  • Patients must be alert, oriented, and have signed an informed consent in accordance with institutional policies and be aware of the investigational nature of the study.
  • Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter

Exclusion Criteria:

  • Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:

    1. Serum creatinine clearance ≤ 50 ml/min
    2. Platelets <100,000/mm3
    3. Absolute neutrophil count (ANC) <1500/mm3
    4. Hemoglobin <8.0 g/dl (the patient may be transfused prior to study entry)
  • History of chronic or active hepatitis
  • Patient has severe or uncontrolled medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
  • Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at time of study entry.
  • Patients with a history of severe hypersensitivity to Taxotere®, Topotecan®, or other drugs formulated with polysorbate 80.
  • Women who are pregnant or breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231855

Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Sponsors and Collaborators
Montefiore Medical Center
Sanofi
GlaxoSmithKline
Investigators
Principal Investigator: Mark H Einstein, M.D., M.S. Montefiore Medical Center and Albert Einstein College of Medicine
  More Information

Publications:
Responsible Party: Mark H. Einstein, Director, Clinical Research for Women's Health, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00231855     History of Changes
Other Study ID Numbers: MMC-04-05-131
Study First Received: September 30, 2005
Last Updated: April 22, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Epithelial Ovarian Cancer
Uterine Cancer
Prior Therapy
Chemotherapy
Recurrence

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Uterine Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Uterine Diseases
Topotecan
Docetaxel
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 21, 2014