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

NCT ID: NCT00652691

Last Updated: 2019-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-08-31
• Study Completion Date: 2016-05-04

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.

Conditions

Ovarian Cancer; Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

cyclophosphamide

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

autologous hematopoietic stem cell transplantation

Intervention Type: PROCEDURE

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark R. Litzow, MD

Role: STUDY_CHAIR

Mayo Clinic

Lawrence A Solberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

References

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.

Reference Type: RESULT

PMID: 19648970 (View on PubMed)

Other Identifiers

P30CA015083

Identifier Type: NIH

Identifier Source: secondary_id

View Link

976101

Identifier Type: OTHER

Identifier Source: secondary_id

1056-98

Identifier Type: OTHER

Identifier Source: secondary_id

976101

Identifier Type: -

Identifier Source: org_study_id