COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Topotecan, High-Dose Cyclophosphamide, Carboplatin, and an Autologous Peripheral Blood Cell Transplant in Treating Patients With Recurrent Ovarian Cancer or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00652691
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : April 8, 2019
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Brief Summary:

RATIONALE: Giving colony-stimulating factors, such as G-CSF help stem cells move from the patient's bone marrow to the blood so they can be collected and stored. Combination chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This randomized trial is studying the side effects and best dose of topotecan when given together with high-dose cyclophosphamide, and carboplatin followed by an autologous peripheral blood stem cell transplant in treating patients with recurrent ovarian cancer or primary peritoneal cancer.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Peritoneal Cavity Cancer Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: topotecan hydrochloride Procedure: autologous hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Phase 1

Detailed Description:


  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 1998
Actual Primary Completion Date : June 5, 2002
Actual Study Completion Date : May 4, 2016

Primary Outcome Measures :
  1. Maximum tolerated dose of topotecan hydrochloride
  2. Toxicity according to NCI criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed ovarian epithelial or primary peritoneal cavity cancer

    • Recurrent, relapsed, or persistent disease meeting 1 or more of the following criteria:

      • 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 chemotherapy
      • 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 registration
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00652691

Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Layout table for investigator information
Study Chair: Mark R. Litzow, MD Mayo Clinic
Principal Investigator: Lawrence A Solberg, M.D. Mayo Clinic
Publications of Results:
Layout table for additonal information
Responsible Party: Mayo Clinic Identifier: NCT00652691    
Other Study ID Numbers: 976101
P30CA015083 ( U.S. NIH Grant/Contract )
976101 ( Other Identifier: Mayo Clinic Cancer Center )
1056-98 ( Other Identifier: Mayo Clinic IRB )
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: March 2018
Keywords provided by Mayo Clinic:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors