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


Phase 1
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Stephen A. Cannistra, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Federal Government

Study ID:

BIDMC-E-010405FB

NCT ID:

NCT00055614

Start Date:

May 2002

Completion Date:

October 2007

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215