Ovarian CancerPhase 2NCT00006028
Gemcitabine Plus Cisplatin in Treating Patients With Ovarian Epithelial Cancer or Primary Peritoneal Cancer That Is Recurrent or Has Not Responded to Platinum-based Chemotherapy
A Phase 2 study testing cisplatin and gemcitabine hydrochloride in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 31 sites in 2 countries.
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 gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- What is being tested?
- cisplatin and gemcitabine hydrochloride
- How many people
- Not given
- Where
- 31 sitesin 2 countries
- Study dates
- Jan 2001to Jan 2007
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed primary ovarian epithelial cancer or primary peritoneal carcinoma
- Recurrent or persistent disease
- Bidimensionally measurable disease by physical examination or medical imaging techniques
- Sonography is acceptable if lesions are clearly defined on initial examination and bidimensionally measurable
- Ascites and pleural effusions are not considered measurable disease
- Must not be eligible for a higher priority Gynecologic Oncology Group protocol
- Must have received one, and only one, prior platinum-based chemotherapy regimen containing carboplatin, cisplatin, or another organoplatinum compound for management of primary disease
- Initial treatment may include high-dose therapy, consolidation, or extended therapy administered after surgical or nonsurgical assessment
- If no prior paclitaxel, a second regimen containing paclitaxel allowed
- Platinum-resistant or refractory (i.e., treatment-free interval after platinum-based therapy of less than 6 months or progressed during platinum-based therapy)
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- GOG 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:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT no greater than 2.5 times ULN
- Alkaline phosphatase no greater than 2.5 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Other:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active infection requiring antibiotics
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- Sensory and motor neuropathy no greater than grade 1
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 3 weeks since prior biologic or immunologic therapy for ovarian or peritoneal cancer
Chemotherapy:
- See Disease Characteristics
- No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
- No prior gemcitabine
- At least 3 weeks since prior chemotherapy for ovarian or peritoneal cancer and recovered
Endocrine therapy:
- At least 1 week since prior hormonal therapy for ovarian or peritoneal cancer
- Concurrent continuation of hormonal replacement therapy allowed
Radiotherapy:
- At least 3 weeks since prior radiotherapy for ovarian or peritoneal cancer and recovered
- No prior radiotherapy to only site of measurable disease
- No prior radiotherapy to more than 25% of bone marrow
Surgery:
- See Disease Characteristics
- At least 3 weeks since prior surgery for ovarian or peritoneal cancer and recovered
Other:
- At least 3 weeks since other prior therapy for ovarian or peritoneal cancer
- No prior cancer treatment that would preclude study
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States30 sites
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
Tuft-New England Medical Center
Boston, Massachusetts, 02111
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103-1489
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3864
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
Ireland Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
Simmons Cancer Center - Dallas
Dallas, Texas, 75390-9032
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
University of Texas Medical Branch
Galveston, Texas, 77555-0587
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
Ellis Fischel Cancer Center
Indianapolis, Indiana, 46285
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
Community Hospital of Los Gatos
Los Gatos, California, 95032
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6188
Brookview Research, Inc.
Nashville, Tennessee, 37203
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1065
About this study
Official title: Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer
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 gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.
Read the detailed description
OBJECTIVES:
- Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols.
- Determine the nature and degree of toxicity of this regimen in this patient population.
- Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients.
- Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.
- Conditions
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Being tested
- cisplatin, gemcitabine hydrochloride
- Keywords
- recurrent ovarian epithelial cancer, primary peritoneal cavity 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.
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 startJan 2001
- Primary completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- 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
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Cheryl A. Brewer, MD, Study chair, University of Illinois College of Medicine at Peoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006028
- Sponsor's protocol ID
- CDR0000068041
- Other IDs
- GOG-0126L
- Status last verified
- Mar 2003
- First submitted
- 5 Jul 2000
- Last updated
- 27 May 2013
- Results posted
- No
Publications
Brewer CA, Blessing JA, Nagourney RA, Morgan M, Hanjani P. Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Nov;103(2):446-50. doi: 10.1016/j.ygyno.2006.03.018. Epub 2006 Apr 27.
PubMed 16643994
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gemcitabine and Cisplatin in Recurrent, Platinum Resistant and Refractory Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00006028
- Acronym / sponsor ID
- CDR0000068041
- Conditions
- Ovarian Cancer, Primary Peritoneal Cavity Cancer
- Keywords
- recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2001
- Primary completion
- Jan 2007 (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 gemcitabine plus cisplatin in treating patients who have primary ovarian epithelial cancer or primary peritoneal cancer that is recurrent or has not responded to platinum-based chemotherapy.
Detailed description
OBJECTIVES:
- Determine the anti-tumor activity of gemcitabine and cisplatin in patients with recurrent or refractory platinum-resistant ovarian epithelial cancer or primary peritoneal carcinoma who have failed on higher priority treatment protocols.
- Determine the nature and degree of toxicity of this regimen in this patient population.
- Correlate ex vivo drug sensitivity and resistance with clinical response to this regimen in these patients.
- Correlate molecular markers of drug responsiveness and cellular apoptosis with ex vivo measures of drug resistance in these patients.
OUTLINE: This is a multicenter study.
Patients receive cisplatin IV over 1 hour followed by gemcitabine IV over 1 hour on days 1 and 8. Courses repeat every 4 weeks in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 5-14 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 | Drug | – |
| gemcitabine 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 27 May 2013.
- Results publication: PubMed 16643994Brewer CA, Blessing JA, Nagourney RA, Morgan M, Hanjani P. Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2006 Nov;103(2):446-50. doi: 10.1016/j.ygyno.2006.03.018. Epub 2006 Apr 27.
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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.
Cheryl A. Brewer, MD study chair
University of Illinois College of Medicine at Peoria
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin and gemcitabine hydrochloride in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Norway. 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?
On the ClinicalTrials.gov record for NCT00006028, which also lists 1 linked publication.
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 27 May 2013.