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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Amy D. Tiersten, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065734

NCT ID:

NCT00003064

Start Date:

January 1997

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neoplasms, Glandular and Epithelial

Name

Location

Herbert Irving Comprehensive Cancer CenterNew York, New York  10032