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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00652691
First received: April 3, 2008
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Maximum tolerated dose of topotecan hydrochloride [ Designated as safety issue: Yes ]
  • Toxicity according to NCI criteria [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: August 1998
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No more than 1 prior treatment regimen for this cancer
  • More than 3 weeks since surgery
  • No prior topotecan hydrochloride
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652691

Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Mark R. Litzow, MD Mayo Clinic
Principal Investigator: Lawrence A Solberg, M.D. Mayo Clinic in Florida
  More Information

Additional Information:
Publications:
Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00652691     History of Changes
Other Study ID Numbers: 976101, P30CA015083, 976101, 1056-98
Study First Received: April 3, 2008
Last Updated: February 18, 2014
Health Authority: United States: Federal Government

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:
Ovarian Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Cyclophosphamide
Carboplatin
Topotecan
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 31, 2014