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

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ClinicalTrials.gov Identifier: NCT00003064

Recruitment Status : Unknown

Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting

First Posted : April 18, 2003

Last Update Posted : January 6, 2014

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

National Cancer Institute (NCI)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer	Biological: filgrastim Drug: carboplatin Drug: etoposide phosphate Drug: paclitaxel Drug: thiotepa Drug: topotecan hydrochloride Procedure: peripheral blood stem cell transplantation	Phase 1 Phase 2

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.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Primary Purpose:	Treatment
Official Title:	Phase I-II Study of Tandem Cycles of High Dose Chemotherapy Followed by Autologous Hematopoietic Stem Cell Support in Women With Persistent, Refractory or Recurrent Advanced (Stage III or IV), Epithelial Ovarian Cancer
Study Start Date :	January 1997

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Ovarian cancer

MedlinePlus related topics: Ovarian Cancer

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Ovarian Epithelial Cancer Fallopian Tube Cancer

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer following at least 3 courses of initial standard platinum based chemotherapy OR have radiologic evidence of recurrence with a CA125 greater than 100
Initial stage IV disease having a complete response following platinum based therapy allowed
No brain metastases
Not eligible for other high priority national or institutional study

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

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00003064

Locations


United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032

Sponsors and Collaborators

Herbert Irving Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators


Study Chair:	Amy D. Tiersten, MD	Herbert Irving Comprehensive Cancer Center

More Information


ClinicalTrials.gov Identifier:	NCT00003064 History of Changes
Obsolete Identifiers:	NCT00034320
Other Study ID Numbers:	CDR0000065734 CPMC-IRB-7866 NCI-G97-1327
First Posted:	April 18, 2003 Key Record Dates
Last Update Posted:	January 6, 2014
Last Verified:	December 2002

Keywords provided by National Cancer Institute (NCI):


recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer

Additional relevant MeSH terms:


Ovarian Neoplasms Neoplasms, Glandular and Epithelial Fallopian Tube 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 Neoplasms by Histologic Type	Fallopian Tube Diseases Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Etoposide phosphate Carboplatin Etoposide Topotecan Thiotepa Antineoplastic Agents Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors

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