Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer

NCT ID: NCT00003064

Last Updated: 2014-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-01-31

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and autologous peripheral stem cell transplantation in treating patients with recurrent or persistent epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose of topotecan with a fixed dose of etoposide phosphate as a component of a multicourse high dose chemotherapy regimen supported by peripheral blood stem cell transplantation in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.
• Evaluate the response, time to progression, disease free survival, and overall survival in this patient population.

OUTLINE: This is a dose escalation study of topotecan.

All patients receive induction therapy consisting of 1 to 2 courses of mobilization therapy. Subcutaneous filgrastim (G-CSF) is given beginning 24 hours after induction dose. Following induction therapy, peripheral blood stem cells (PBSC) are harvested. After patients receive high dose paclitaxel and carboplatin chemotherapy, a portion of the PBSC are reinfused. When patients recover from the paclitaxel/carboplatin chemotherapy the administration of topotecan and etoposide phosphate begins. Topotecan is administered, as a 72 hour continuous infusion, according to a dose escalation schedule with a fixed dose of etoposide phosphate. A second portion of PBSC are reinfused after topotecan/etoposide phosphate chemotherapy. A course of thiotepa is given along with the final portion of PBSC after treatment with topotecan and etoposide phosphate.

Dose escalation of topotecan continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity.

Patients are followed every 3 months for 1 year and every 4 months thereafter to determine progression free and overall survival.

PROJECTED ACCRUAL: Approximately 25-30 patients will be accrued for the phase I portion of this study, and 25 more patients will be accrued for the phase II portion.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

filgrastim

Intervention Type: BIOLOGICAL

carboplatin

Intervention Type: DRUG

etoposide phosphate

Intervention Type: DRUG

paclitaxel

Intervention Type: DRUG

thiotepa

Intervention Type: DRUG

topotecan hydrochloride

Intervention Type: DRUG

peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• Greater than 2 months

Hematopoietic:

• WBC greater than 3000/mm3
• Absolute neutrophil count greater than 1500/mm3
• Platelet count greater than 100,000/mm3

Hepatic:

• Bilirubin less than 1.5 times normal
• SGOT or SGPT less than 1.5 times normal
• PT/PTT within normal limits

Renal:

• BUN less than 1.5 times normal
• Creatinine less than 1.5 times normal
• Creatinine clearance greater than 55 mL/min

Cardiovascular:

• LVEF at least 45%

Other:

• Not pregnant or nursing
• HIV negative
• No prior malignancy other than curatively treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or breast cancer if the risk of recurrence is sufficiently low
• No serious illness that would prevent treatment

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 weeks since prior radiotherapy

Surgery:

• Not specified

Other:

• No concurrent acetaminophen

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

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Herbert Irving Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Amy D. Tiersten, MD

Role: STUDY_CHAIR

Herbert Irving Comprehensive Cancer Center

Locations

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Countries

United States

Other Identifiers

CPMC-IRB-7866

Identifier Type: -

Identifier Source: secondary_id

NCI-G97-1327

Identifier Type: -

Identifier Source: secondary_id

CDR0000065734

Identifier Type: -

Identifier Source: org_study_id

NCT00034320

Identifier Type: -

Identifier Source: nct_alias