Ovarian CancerPhase 2NCT00005051
Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
A Phase 2 study testing carboplatin, cisplatin and paclitaxel in people with Ovarian Cancer, run by NYU Langone Health at 10 sites 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial 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?
- carboplatin, cisplatin and paclitaxel
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Aug 1999to Mar 2003
- 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 confirmed advanced ovarian epithelial carcinoma, regardless of quantity of disease post-surgery
- Stage IC, II, III, or IV
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- SGOT no greater than 3 times upper limit of normal
- Bilirubin no greater than 2.0 mg/dL
- No clinically significant hepatic disorder
Renal:
- Creatinine no greater than 1.5 mg/dL OR
- Creatinine clearance greater than 60 mL/min
- No clinically significant renal disorder
Cardiovascular:
- No clinically significant cardiovascular condition
Other:
- Normal GI function allowing reliable administration of oral medication
- No active infection requiring systemic medical therapy within past week
- No other clinically significant medical condition (e.g., endocrine/metabolic or autoimmune disorder)
- No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No dementia or altered mental status that would preclude consent
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for ovarian epithelial carcinoma
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for ovarian epithelial carcinoma
Surgery:
- See Disease Characteristics
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
New York Hospital Medical Center of Queens
Fresh Meadows, New York, 11365
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-3236
Saint Vincent Catholic Medical Center of New York
New York, New York, 10011
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, 10016
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
New York, New York, 10019
New York Weill Cornell Cancer Center at Cornell University
New York, New York, 10021
Mount Sinai Medical Center, NY
New York, New York, 10029
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, 10032
Albert Einstein Clinical Cancer Center
The Bronx, New York, 10461
New York Medical College
Valhalla, New York, 10595
About this study
Official title: Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.
Read the detailed description
OBJECTIVES:
- Determine the toxicity and tolerance of sequential therapy with prolonged
- Determine the response rate and time to progression in this patient
- Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route.
OUTLINE:
- Regimen A: Patients receive cisplatin IV over 60-90 minutes on day 1 of each course. Topotecan IV is administered continuously on days 1-14 of course 1. Oral topotecan is administered twice daily on days 1-14 for courses 2, 3, and 4. Treatment repeats every 28 days for 4 courses.
- Regimen B: After completion of regimen A, patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
PROJECTED ACCRUAL: A total of 30 patients (15 per arm) will be accrued for this study.
- Conditions
- Ovarian Cancer
- Being tested
- carboplatin, cisplatin, paclitaxel, topotecan hydrochloride
- Keywords
- stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV 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.
carboplatinDrug
cisplatinDrug
paclitaxelDrug
topotecan hydrochlorideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startAug 1999
- Primary completionMar 2003
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)
- Responsible party
- Sponsor
- Investigators
- Howard S. Hochster, MD, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005051
- Sponsor's protocol ID
- CDR0000067644
- Other IDs
- NYU-9913, NCI-G00-1720
- Status last verified
- Dec 2003
- First submitted
- 6 Apr 2000
- Last updated
- 9 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens: Cisplatin-Prolonged Oral Topotecan (C-PORT) Followed by Paclitaxel/Carboplatin (PC)
- ClinicalTrials.gov ID
- NCT00005051
- Acronym / sponsor ID
- CDR0000067644
- Conditions
- Ovarian Cancer
- Keywords
- stage I ovarian epithelial cancer, stage II ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV 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
- Aug 1999
- Primary completion
- Mar 2003 (actual)
- First posted
- 27 Jan 2003 (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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer.
Detailed description
OBJECTIVES:
- Determine the toxicity and tolerance of sequential therapy with prolonged
- Determine the response rate and time to progression in this patient
- Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route.
OUTLINE:
- Regimen A: Patients receive cisplatin IV over 60-90 minutes on day 1 of each course. Topotecan IV is administered continuously on days 1-14 of course 1. Oral topotecan is administered twice daily on days 1-14 for courses 2, 3, and 4. Treatment repeats every 28 days for 4 courses.
- Regimen B: After completion of regimen A, patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses.
PROJECTED ACCRUAL: A total of 30 patients (15 per arm) 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 |
|---|---|---|
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| paclitaxel | Drug | – |
| topotecan hydrochloride | 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 9 Nov 2012.
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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
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, cisplatin and paclitaxel in people with Ovarian Cancer, run by NYU Langone Health at 10 sites 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 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 9 Nov 2012.