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A Dose Seeking Trial of Topotecan Combined With High-Dose Cyclophosphamide and Carboplatin With Peripheral Blood Stem Cell Transplant for the Treatment of Relapsed Ovarian Cancer and Primary Peritoneal Cancer

Phase 1
18 Years
70 Years
Open (Enrolling)
Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

A Dose Seeking Trial of Topotecan Combined With High-Dose Cyclophosphamide and Carboplatin With Peripheral Blood Stem Cell Transplant for the Treatment of Relapsed Ovarian Cancer and Primary Peritoneal Cancer


- To determine the maximum tolerated dose of topotecan hydrochloride combined with
high-dose cyclophosphamide and carboplatin in the setting of autologous peripheral
blood stem cell transplantation for relapsed, recurrent, or persistent ovarian
epithelial or primary peritoneal cavity cancer.

- To assess the toxicity of this regimen.

OUTLINE: This is a dose escalation study of topotecan.

- Autologous hematopoietic stem cell collection: Patients receive filgrastim
subcutaneously (SC) daily for 5 days. Patients undergo leukapheresis per standard
practice until a minimum of 2 x10^6 CD34+ cells/kg are collected and cryopreserved.

- High-dose chemotherapy: Patients receive topotecan hydrochloride IV, cyclophosphamide
IV, and carboplatin IV over 8 hours on days -6 to -3.

- Autologous peripheral stem cell reinfusion: Patients undergo autologous peripheral
blood stem cell transplantation on day 0. Patients also receive sargramostim SC daily
beginning on day 5 and continuing until blood counts recover.

After completion of study therapy, patients are followed monthly for 3 months, every 3
months for 2 years, and then every 6 months for 5 years.

Inclusion Criteria


- Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer

- Recurrent, relapsed, or persistent disease meeting 1 or more of the following

- Patients with a positive second-look laparotomy who are not candidates for
higher priority GOG protocols

- Largest mass of recurrent disease ≤ 0.2 cm achieved by surgery or

- Achievement of complete response to 1 prior regimen of platinum-based
chemotherapy with relapse > 6 months from last chemotherapy

- Achievement of partial response to 1 platinum-based chemotherapy regimen
prior to study

- Histological proof of disease recurrence with or without a rising serum CA-125
level (relapsed or recurrent disease)

- The following histological cell types are allowed:

- Clear-cell adenocarcinoma

- Endometrioid adenocarcinoma

- Mixed epithelial carcinoma

- Mucinous adenocarcinoma

- Serous adenocarcinoma

- Undifferentiated carcinoma

- Must have unilateral bone marrow aspirate and biopsy with cytogenetics without
evidence of metastatic ovarian carcinoma by conventional morphology within 1 month of

- Not eligible for GOG-164


- ECOG performance status 0-2

- Creatinine ≤ 1.5 mg/dL

- Total bilirubin ≤ 2.0 mg/dL (≤ 5.0 mg/dL with metastatic disease)

- AST ≤ 2 times upper limit of normal (ULN) (≤ 600 units/mL with metastatic disease)

- Alkaline phosphatase ≤ 2 times ULN (unless related to metastatic disease)

- ANC ≥ 1,000/mm^3

- Platelets ≥ 100,000/mm^3

- Cardiac ejection fraction ≥ 45% by rest ECHO or MUGA

- FEV_1 ≥ 50% of predicted

- HIV negative

- No uncontrolled infection

- No severe medical or psychiatric illness, including any of the following:

- Renal failure

- Brittle insulin dependent diabetes mellitus

- Congestive heart failure

- History of myocardial infarction within the past 3 months

- Significant arrhythmia requiring medication

- Poorly controlled hypertension (diastolic blood pressure >100 mm Hg)

- History of hospitalization for severe depression or psychosis

- Significant non-neoplastic pulmonary disease

- Current alcohol or drug abuse.

- Active infection

- Active peptic ulcer disease

- No prior malignancy within the past 5 years except adequately treated basal cell or
squamous cell carcinoma of the skin or in situ cervical carcinoma


- See Disease Characteristics

- No more than 1 prior treatment regimen for this cancer

- More than 3 weeks since surgery

- No prior topotecan hydrochloride

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of topotecan hydrochloride

Safety Issue:


Principal Investigator

Mark R. Litzow, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

August 1998

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • peritoneal cavity cancer
  • ovarian clear cell tumor with proliferating activity
  • ovarian endometrioid adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • recurrent ovarian epithelial cancer
  • ovarian mucinous cystadenocarcinoma
  • ovarian serous cystadenocarcinoma
  • ovarian undifferentiated adenocarcinoma
  • Ovarian Neoplasms
  • Peritoneal Neoplasms