Ovarian CancerPhase 2NCT00004083
Liposomal Cisplatin in Treating Patients With Recurrent Ovarian Cancer
A Phase 2 study testing cisplatin liposomal in people with Ovarian Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- cisplatin liposomal
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 1999to Dec 1999
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Pilot Study of SPI-77 (Stealth Liposomal Cisplatin) in Patients With Recurrent Platinum-Sensitive Ovarian Cancer
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- cisplatin liposomal
- Keywords
- stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin liposomalDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2004 (estimated)
- Study startFeb 1999
- Primary completionDec 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Howard S. Hochster, MD, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004083
- Sponsor's protocol ID
- CDR0000067294
- Other IDs
- P30CA016087, NYU-9871, SEQUUS-77-21, NCI-G99-1579
- Status last verified
- Mar 2011
- First submitted
- 10 Dec 1999
- Last updated
- 28 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Study of SPI-77 (Stealth Liposomal Cisplatin) in Patients With Recurrent Platinum-Sensitive Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00004083
- Acronym / sponsor ID
- CDR0000067294
- Conditions
- Ovarian Cancer
- Keywords
- stage IV ovarian epithelial cancer, recurrent ovarian epithelial cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 1999
- Primary completion
- Dec 1999 (actual)
- First posted
- 14 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cisplatin liposomal | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard S. Hochster, MD study chair
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin liposomal in people with Ovarian Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2011.