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

Primary Purpose

Ovarian Cancer, Peritoneal Cavity Cancer

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

filgrastim

carboplatin

cyclophosphamide

topotecan hydrochloride

autologous hematopoietic stem cell transplantation

peripheral blood stem cell transplantation

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring 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

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Maximum tolerated dose of topotecan hydrochloride

Toxicity according to NCI criteria

Secondary Outcome Measures

Full Information

NCT ID

NCT00652691

First Posted

April 3, 2008

Last Updated

April 4, 2019

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00652691

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

August 1998 (Actual)

Primary Completion Date

June 5, 2002 (Actual)

Study Completion Date

May 4, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer, Peritoneal Cavity Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

48 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Drug

Intervention Name(s)

carboplatin

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Drug

Intervention Name(s)

topotecan hydrochloride

Intervention Type

Procedure

Intervention Name(s)

autologous hematopoietic stem cell transplantation

Intervention Type

Procedure

Intervention Name(s)

peripheral blood stem cell transplantation

Primary Outcome Measure Information:

Title

Maximum tolerated dose of topotecan hydrochloride

Title

Toxicity according to NCI criteria

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark R. Litzow, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lawrence A Solberg, M.D.

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

19648970

Citation

Litzow MR, Peethambaram PP, Safgren SL, Keeney GL, Ansell SM, Dispenzieri A, Elliott MA, Gastineau DA, Gertz MA, Inwards DJ, Lacy MQ, Micallef IN, Porrata LF, Lingle WL, Hartmann LC, Frost MH, Barrette BA, Long HJ, Suman VJ, Reid JM, Ames MM, Kaufmann SH. Phase I trial of autologous hematopoietic SCT with escalating doses of topotecan combined with CY and carboplatin in patients with relapsed or persistent ovarian or primary peritoneal carcinoma. Bone Marrow Transplant. 2010 Mar;45(3):490-7. doi: 10.1038/bmt.2009.181. Epub 2009 Aug 3.

Results Reference

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

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