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Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
This study has been completed.
First Received: March 6, 2003   Last Updated: February 6, 2009   History of Changes
Sponsored by: Beth Israel Deaconess Medical Center
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00055614
  Purpose

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 Intervention Phase
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: topotecan hydrochloride
Procedure: adjuvant therapy
Phase I

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Topotecan hydrochloride Topotecan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 20
Study Start Date: May 2002
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

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

Hepatic

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

Renal

  • Creatinine clearance at least 60 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent immunotherapy

Chemotherapy

  • 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

Radiotherapy

  • No prior abdominopelvic radiotherapy
  • No concurrent radiotherapy

Surgery

  • See Disease Characteristics
  • No concurrent surgery

Other

  • No other concurrent antitumor therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055614

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

Additional Information:
No publications provided

Study ID Numbers: CDR0000269138, BIDMC-E-010405FB, NEDH-E-010405FB
Study First Received: March 6, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00055614     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Study placed in the following topic categories:
Fallopian Tube Cancer
Ovarian Neoplasms
Digestive System Neoplasms
Gonadal Disorders
Adjuvants, Immunologic
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Ovarian Epithelial Cancer
Abdominal Neoplasms
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Genital Diseases, Female
Digestive System Diseases
Peritoneal Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Peritoneal Neoplasms
Topotecan
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Digestive System Neoplasms
Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Urogenital Neoplasms
Ovarian Diseases
Abdominal Neoplasms
Pharmacologic Actions
Fallopian Tube Neoplasms
Fallopian Tube Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Peritoneal Neoplasms
Topotecan
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009