Know Cancer

forgot password

A Phase I Study of Sequential Prolonged Oral Topotecan (IND# 58,131) and Prolonged Oral Etoposide as Second Line Therapy in Ovarian, Peritoneal or Tubal Carcinoma

Phase 1
18 Years
Not Enrolling
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase I Study of Sequential Prolonged Oral Topotecan (IND# 58,131) and Prolonged Oral Etoposide as Second Line Therapy in Ovarian, Peritoneal or Tubal Carcinoma

OBJECTIVES: I. Determine the maximum tolerated dose of sequential prolonged topotecan and
prolonged etoposide as second line therapy in patients with recurrent ovarian epithelial,
peritoneal, or tubal cancer. II. Determine the nature and degree of toxicity of this
treatment regimen in this patient population. III. Evaluate the response rate and time to
disease progression in these patients.

OUTLINE: This is a dose escalation study. Patients receive oral topotecan daily on days 1-5
and oral etoposide daily on days 8-10. Courses repeat every 28 days in the absence of
disease progression or unacceptable side effects. Patients achieving partial or complete
response or stable disease continue treatment for at least 4-6 courses. Cohorts of 3-6
patients receive topotecan and etoposide on increasing numbers of days until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which no greater than
1 of 6 patients experiences dose limiting toxicity. Patients are followed every 3 months or
until death.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 12 months.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, peritoneal, or tubal
cancer Epithelial cell types Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous
adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial
carcinoma Transitional cell Malignant Brenner's tumor Adenocarcinoma not otherwise
specified Measurable or evaluable disease No brain or leptomeningeal metastases No
symptomatic bowel involvement of ovarian cancer Not eligible for higher priority GOG phase
II or III study

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not
specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at
least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT/SGPT/GGT no
greater than 3 times normal Alkaline phosphatase no greater than 3 times normal No acute
hepatitis Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance greater than
50 mL/min Other: No septicemia or severe infection Body surface area at least 1 m2
Adequate intestinal function (i.e., does not require IV hydration or nutritional support)
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception 3 months prior to and during study No other malignancies within the past 5
years except curatively treated skin cancer No other severe medical problems that would
prevent compliance No condition of the GI tract that would affect GI absorption and
motility No severe gastrointestinal bleeding

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: No
prior topotecan, other camptothecin analogs, or etoposide At least 1 prior
cisplatin/paclitaxel based regimen At least 3 weeks since prior chemotherapy and recovered
No more than 2 prior cytotoxic chemotherapy regimens No other concurrent chemotherapy
Endocrine therapy: No concurrent hormonal therapy for cancer Radiotherapy: At least 3
weeks since prior radiotherapy to no more than 10% of the bone marrow and recovered No
concurrent radiotherapy Surgery: Not specified Other: At least 28 days or 5 half lives
since prior investigational drugs (including cytotoxic drugs) No concurrent metoclopramide
or cisapride for maintaining gastric motility or emptying No chronic H2 antagonists,
proton pump inhibitors, or antacids for gastritis, gastroesophageal reflux disease, or
gastric or duodenal ulcers Intermittent antacids allowed, if no antacids 6 hours prior to
and 90 minutes after topotecan

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter G. Rose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

September 1999

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • ovarian undifferentiated adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian clear cell cystadenocarcinoma
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Brenner tumor
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Cooper Hospital/University Medical Center Camden, New Jersey  08103
Ireland Cancer Center Cleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Mercy Medical Center, Inc. Baltimore, Maryland  21202