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

Beth Israel Lahey Health

Status and phase: Completed; Phase 1

Conditions: Primary Peritoneal Cavity Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Procedure: adjuvant therapy; Drug: topotecan hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00055614

CDR0000269138 (Registry Identifier)

NEDH-E-010405FB

BIDMC-E-010405FB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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