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A Phase II Pilot Study of SPI-77 (Stealth Liposomal Cisplatin) in Patients With Recurrent Platinum-Sensitive Ovarian Cancer

Phase 2
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Phase II Pilot Study of SPI-77 (Stealth Liposomal Cisplatin) in Patients With Recurrent Platinum-Sensitive Ovarian Cancer

OBJECTIVES: I. Determine the objective response rate in patients with recurrent platinum
sensitive ovarian epithelial cancer treated with cisplatin liposomal (SPI-77). II. Determine
the time to response, duration of response, time to progression, and survival in these
patients treated with this regimen. III. Characterize the safety of this regimen in these

OUTLINE: Patients receive cisplatin liposomal (SPI-77) IV over a minimum of 4 hours on day
1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or
unacceptable toxicity. Patients with clinical benefit after 6 courses may receive additional
courses upon approval by the pharmaceutical sponsor. Patients are followed every 2 months
for a minimum of 6 months and then periodically for survival.

PROJECTED ACCRUAL: A total of 26-63 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically proven recurrent ovarian
epithelial cancer Metastatic disease allowed Must have received prior platinum containing
chemotherapy Must be considered platinum sensitive and have had the following: Response to
a prior platinum containing regimen No disease progression during prior platinum
containing regimen Disease free interval of greater than 6 months following platinum
containing regimen At least 1 bidimensionally measurable lesion No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no
greater than 2.0 mg/dL AST no greater than 2 times upper limit of normal Albumin at least
2.5 g/dL Renal: Creatinine clearance at least 50 mL/min Cardiovascular: No uncontrolled
heart disease or abnormal symptomatic cardiac function Other: Must have had a baseline
hearing evaluation including an audiogram Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception No acute infection requiring systemic
therapy No signs of confusion or disorientation or prior major psychiatric illness that
may preclude informed consent No grade 3 or 4 neurotoxicity from prior anticancer
treatment or grade 2 or higher neuropathy from other causes No requirement for total
parental nutrition with lipids No prior allergic reaction to cisplatin or platinum
containing products

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics No prior SPI-77 At least 3 weeks since other prior chemotherapy (6 weeks
for nitrosoureas, mitomycin, or suramin) No concurrent antineoplastic agents Endocrine
therapy: No concurrent hormonal anticancer therapy Radiotherapy: At least 2 weeks since
prior radiotherapy No concurrent radiotherapy Surgery: At least 2 weeks since prior major
surgery for cancer Other: At least 30 days since other prior investigational agent No
other concurrent investigational agents

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Howard S. Hochster, MD

Investigator Role:

Study Chair

Investigator Affiliation:

New York University School of Medicine


United States: Federal Government

Study ID:




Start Date:

February 1999

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • Ovarian Neoplasms



Kaplan Cancer Center New York, New York  10016