Clinical trial NCT00055614: Topotecan in Treating Patients With Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Official title: Phase I Study of Oral Topotecan as Consolidation for Patients With Mullerian Origin Tumors (Ovary, Tube, Peritoneum)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Keywords: stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
primary peritoneal cavity cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-03-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Stephen A. Cannistra, MD
role: STUDY_CHAIR
References: