Liposomal Cisplatin in Treating Patients With Recurrent Ovarian Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00004083
First received: December 10, 1999
Last updated: March 25, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: cisplatin liposomal
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Pilot Study of SPI-77 (Stealth Liposomal Cisplatin) in Patients With Recurrent Platinum-Sensitive Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Study Start Date: February 1999
Primary Completion Date: December 1999 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004083

Locations
United States, New York
Kaplan Cancer Center
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
Investigators
Study Chair: Howard S. Hochster, MD New York University School of Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00004083     History of Changes
Other Study ID Numbers: CDR0000067294, P30CA016087, NYU-9871, SEQUUS-77-21, NCI-G99-1579
Study First Received: December 10, 1999
Last Updated: March 25, 2011
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian 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
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 20, 2014