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Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00055614
Recruitment Status : Completed
First Posted : March 7, 2003
Last Update Posted : June 26, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of topotecan in treating patients who have advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer Drug: topotecan hydrochloride Procedure: adjuvant therapy Phase 1

Detailed Description:


  • Determine the maximum tolerated dose and duration of prolonged topotecan as maintenance in patients with advanced ovarian epithelial, fallopian tube, or primary peritoneal cancer with complete clinical response after platinum-based chemotherapy.
  • Determine the safety of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral topotecan twice daily for 21 days. Treatment repeats every 28 days for up to 6 months in the absence of unacceptable toxicity or disease progression.

Patients who tolerate course 1 may receive an escalated dose of topotecan for subsequent courses. The maximum tolerated dose is defined as the dose tolerated by the majority of the patients.

Patients are followed every 2 months for at least 6 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Primary Purpose: Treatment
Official Title: Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)
Study Start Date : May 2002
Actual Study Completion Date : October 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal serous cancer

    • Stage IIIB, IIIC, or IV
    • Surgically staged and debulked
  • Complete clinical response after first-line platinum-based chemotherapy (cisplatin or carboplatin) defined by all of the following criteria:

    • No evidence of cancer by history or physical examination
    • CA 125 no greater than 35 units/mL
    • No evidence of residual cancer on CT scan of the abdomen/pelvis and chest x-ray
  • Must have received at least 5 courses of first-line chemotherapy



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Granulocyte count at least 1,200/mm^3
  • Platelet count at least 90,000/mm^3


  • Bilirubin normal
  • ALT and AST less than 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase less than 1.5 ULN


  • Creatinine clearance at least 60 mL/min


Biologic therapy

  • No concurrent immunotherapy


  • See Disease Characteristics
  • At least 3 weeks since prior first-line chemotherapy
  • At least 3 years since other prior chemotherapy (other than first-line chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer)
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent hormonal therapy


  • No prior abdominopelvic radiotherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • No concurrent surgery


  • No other concurrent antitumor therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00055614

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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Study Chair: Stephen A. Cannistra, MD Beth Israel Deaconess Medical Center

Layout table for additonal information Identifier: NCT00055614     History of Changes
Other Study ID Numbers: BIDMC-E-010405FB
CDR0000269138 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: March 7, 2003    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: April 2007
Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
Additional relevant MeSH terms:
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Fallopian Tube Neoplasms
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Fallopian Tube Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents