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

Ovarian Cancer Clinical Trial

Official title:

Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00055614
• Other study ID #: BIDMC-E-010405FB
• Secondary ID: CDR0000269138NED
• Status: Completed
• Phase: Phase 1
• First received: March 6, 2003
• Last updated: June 25, 2013
• Start date: May 2002
• Est. completion date: October 2007

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• topotecan hydrochloride

Procedure:
• adjuvant therapy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States,