Peritoneal CancerPhase 2NCT00061308
Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer
A Phase 2 study testing Topotecan and Gemcitabine in people with Peritoneal Cancer and Ovarian Cancer, run by GlaxoSmithKline at 19 sites in 2 countries.
Trial summary
This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Peritoneal Cancer, Ovarian Cancer, Neoplasms, Ovarian
- What is being tested?
- Topotecan and Gemcitabine
- How many people
- 75 participants
- Where
- 19 sitesin 2 countries
- Study dates
- Dec 2002to Sep 2004
- 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
Who may be able to join
- Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease.
- At least 4 weeks since last surgery or radiation therapy.
- Must have had a treatment-free interval of greater than 6 months following response to platinum.
- ECOG performance status of 0,1, or 2.
Who cannot join
- Women of child-bearing potential that do not practice adequate contraception.
- Pregnant or lactating.
- Received more than one primary chemotherapy regimen.
- Concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years.
- Active uncontrolled infection requiring antibiotics.
- Concurrent severe medical problems unrelated to the malignancy which would limit full compliance with the study.
Show all 10Show fewer
- Received radiation to more than 10% of bone.
- Prior treatment with topotecan or gemcitabine.
- Hypersensitivity to camptothecin or nucleoside analogues.
- Use of an investigational agent within 30 days.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States15 sites
GSK Investigational Site
Abington, Pennsylvania, 19001-3788
GSK Investigational Site
Chapel Hill, North Carolina, 27599-7570
GSK Investigational Site
Chattanooga, Tennessee, 37403
GSK Investigational Site
Columbus, Georgia, 31902
GSK Investigational Site
Greenville, South Carolina, 29601
GSK Investigational Site
Hattiesburg, Mississippi, 39401
GSK Investigational Site
Hinsdale, Illinois, 60521
GSK Investigational Site
Hollywood, Florida, 33021
GSK Investigational Site
Lansing, Michigan, 48912
GSK Investigational Site
Los Gatos, California, 95032
GSK Investigational Site
Rochester, New York, 14620
GSK Investigational Site
Saint Louis, Montana, 63117
GSK Investigational Site
Santa Rosa, California, 95403
GSK Investigational Site
Southfield, Michigan, 48075
GSK Investigational Site
Washington D.C., District of Columbia, 20010
Canada4 sites
GSK Investigational Site
Calgary, Alberta, T2N 4N2
GSK Investigational Site
Ottawa, Ontario, K1H 1C4
GSK Investigational Site
Toronto, Ontario, M4N 3M5
GSK Investigational Site
Vancouver, British Columbia, V5Z 4E6
About this study
Official title: An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer
This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment.
Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.
- Being tested
- Topotecan, Gemcitabine
- Keywords
- Ovarian cancer, peritoneal cancer, cancer, Fallopian cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopotecanDrug
GemcitabineDrug
Also called Topotecan
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Secondary outcomes (1)
response duration time to response time to progression survival safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2003 (estimated)
- Study startDec 2002
- Primary completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal CancerStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, PhD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061308
- Sponsor's protocol ID
- 104864/627
- Status last verified
- Mar 2013
- First submitted
- 23 May 2003
- Last updated
- 9 Jun 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00061308
- Acronym / sponsor ID
- 104864/627
- Keywords
- Ovarian cancer, peritoneal cancer, cancer, Fallopian cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Sep 2004 (actual)
- First posted
- 28 May 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.
This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment.
Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have had one prior platinum-based chemotherapy regimen for the treatment of primary disease.
- At least 4 weeks since last surgery or radiation therapy.
- Must have had a treatment-free interval of greater than 6 months following response to platinum.
- ECOG performance status of 0,1, or 2.
Key exclusion criteria (10 listed)
- Women of child-bearing potential that do not practice adequate contraception.
- Pregnant or lactating.
- Received more than one primary chemotherapy regimen.
- Concomitant or previous malignancies with the exception of adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, incidental carcinoid, or other cancer from which the patient has been disease free for 5 years.
- Active uncontrolled infection requiring antibiotics.
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 |
|---|---|---|
| Topotecan | Drug | – |
| GemcitabineAlso: Topotecan | Drug | – |
Primary outcome
response rate
1 secondary outcome
response duration time to response time to progression survival safety
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 Jun 2017.
- A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters.Link provided by the sponsor.
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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.
GSK Clinical Trials, MD, PhD study director
GlaxoSmithKline
19 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 Topotecan and Gemcitabine in people with Peritoneal Cancer and Ovarian Cancer, run by GlaxoSmithKline at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. 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 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. 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.
What does the primary outcome measure?
response rate. It is what the study was designed to measure, not a finding.
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 Jun 2017.