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Cisplatin

cisplatin liposomal

Howard S. Hochster, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of liposomal cisplatin in treating patients who have recurrent 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 patients.

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.

Liposomal Cisplatin in Treating Patients With Recurrent Ovarian Cancer

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

National Cancer Institute (NCI)

NYU Langone Health

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Respiratory Aspiration

Osteosarcoma

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Soft Tissue Sarcoma

Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.

The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2

Cisplatin liposomal

Renu Gupta, MD

Richard Gorlick, MD

Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.

Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung

Phase Ib/IIa Study of SLIT Cisplatin by Inhalation in the Treatment of Patients Wtih Relapsed/Progressive Osteosarcoma Metastatic to the Lung

Insmed Incorporated

Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles.

Cisplatin liposomal

Cisplatin Liposomal 24 mg/m2

The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2

Cisplatin liposomal

Cisplatin Liposomal 36 mg/m2

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Margaret Galluzzi

CR/PR

Histological response

Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation

The Study Medication Was to be Considered Effective if the Population Response Rate Was Found to be Greater Than 20% and Individuals Who Demonstrated a CR or PR or Whose Tumours Demonstrated a Grade 3 or 4 Histologic Response at the Time of Surgery.

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Liposomal Cisplatin in Treating Patients With Recurrent Ovarian Cancer	NCT00004083	Ovarian Cancer	cisplatin lipos...	18 Years -	NYU Langone Health
Liposomal Cisplatin in Treating Patients With Recurrent Ovarian Cancer	NCT00004083	Ovarian Cancer	cisplatin lipos...	18 Years -	NYU Langone Health
Inhalation SLIT Cisplatin (Liposomal) for the Treatment of Osteosarcoma Metastatic to the Lung	NCT00102531	Osteosarcoma Me...	Cisplatin lipos...	13 Years - 50 Years	Insmed Incorporated

Spots Global Cancer Trial Database for cisplatin liposomal