NCT00004083

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 1999

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
4.8 years until next milestone

First Posted

Study publicly available on registry

September 14, 2004

Completed
Last Updated

March 28, 2011

Status Verified

March 1, 2011

Enrollment Period

10 months

First QC Date

December 10, 1999

Last Update Submit

March 25, 2011

Conditions

Ovarian Cancer

Keywords

stage IV ovarian epithelial cancerrecurrent ovarian epithelial cancer

Interventions

cisplatin liposomalDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Kaplan Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

SPI-77, liposomal

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Howard S. Hochster, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 1999

First Posted

September 14, 2004

Study Start

February 1, 1999

Primary Completion

December 1, 1999

Last Updated

March 28, 2011

Record last verified: 2011-03

Locations

US(1)