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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003064
First Posted: April 18, 2003
Last Update Posted: January 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 30
Study Start Date: January 1997
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 Submitted: November 1, 1999
First Posted: April 18, 2003
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
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Etoposide phosphate
Carboplatin
Etoposide
Topotecan
Thiotepa
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors