Ovarian CancerPhase 2NCT00267696
Study of Gemcitabine/Carboplatin/Bevacizumab to Treat Ovarian, Fallopian Tube or Primary Peritoneal Cancer
A Phase 2 study testing Bevacizumab, Gemcitabine and Carboplatin in people with Ovarian Cancer and Fallopian Tube Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Bevacizumab, Gemcitabine and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment.
- Disease must be detected by CT or CA125 level must be elevated or cancerous ascites must be present.
- History of at least one therapy of platinum based chemotherapy.
Who cannot join
- Participation in another experimental drug study
- Heart disease or high blood pressure
- History of a stroke within the past 6 months
- Vascular disease, or bleeding problems
- Brain cancer
- Major Surgical Procedure within 28 days prior to start date
Show all 14Show fewer
- Minor surgical procedures within 7 days prior to start date
- Pregnant or lactating
- Abdominal or bowel problems like bleeding
- History of abdominal fistula, GI perforation or Intra-abdominal abscess
- Serious, non-healing wound, ulcer or bone fracture
- Acute hepatitis
- Active infections requiring antibiotics
- Inability to comply with study or follow up procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University & James Cancer Hospital
Columbus, Ohio, 43210
About this study
Official title: A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.
The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.
Read the detailed description
In this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects, participation can continue up to 2 years. The study is being done to find the effectiveness, safety and tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of new blood vessels in the body. It is part of this study to see if stopping the growth of new blood vessels in the body will help stop the growth and the spread of cancer. The other two chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the treatment of ovarian cancer.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Being tested
- Bevacizumab, Gemcitabine, Carboplatin
- Keywords
- ovarian cancer, platinum sensitive cancer, fallopian tube cancer, peritoneal cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin®
Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.
GemcitabineDrug
A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle
CarboplatinDrug
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/carboplatin/bevacizumab | Experimental | A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle. Receives: Drug: Bevacizumab; Drug: Gemcitabine; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.
Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.
Measured: up to 6 months
Secondary outcomes (1)
Overall Survival for Patients Treated With the Regimen.
The period of time from study entry until disease progression or date of last contact.
Measured: To progression of Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionSep 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Eli Lilly and Company
- Responsible party
- Principal investigator, Larry Copeland, Ohio State University Comprehensive Cancer Center
- Investigators
- Larry J. Copeland, MD, Principal investigator, Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00267696
- Sponsor's protocol ID
- OSU-05070
- Status last verified
- Apr 2015
- First submitted
- 19 Dec 2005
- Last updated
- 30 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Richardson DL, Backes FJ, Seamon LG, Zanagnolo V, O'Malley DM, Cohn DE, Fowler JM, Copeland LJ. Combination gemcitabine, platinum, and bevacizumab for the treatment of recurrent ovarian cancer. Gynecol Oncol. 2008 Dec;111(3):461-6. doi: 10.1016/j.ygyno.2008.08.011. Epub 2008 Sep 30.
PubMed 18829088
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemcitabine/Carboplatin/Bevacizumab in Platinum Sensitive Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients.
- ClinicalTrials.gov ID
- NCT00267696
- Acronym / sponsor ID
- OSU-05070
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- Keywords
- ovarian cancer, platinum sensitive cancer, fallopian tube cancer, peritoneal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc., Eli Lilly and Company
- Study start
- Nov 2005
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Dec 2005 (estimated)
- Results
- Posted 30 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effectiveness, safety and tolerability of the drug combination: gemcitabine, carboplatin and bevacizumab in patients that have been diagnosed with platinum sensitive recurrent ovarian cancer, fallopian tube or primary peritoneal cancer.
Detailed description
In this study participants will receive the drug combination gemcitabine/carboplatin and bevacizumab once every two weeks. As long as there is evidence that the tumor is not growing and the participant is not experiencing any unacceptable side effects, participation can continue up to 2 years. The study is being done to find the effectiveness, safety and tolerability of this combination of chemotherapy drugs. Bevacizumab affects the growth of new blood vessels in the body. It is part of this study to see if stopping the growth of new blood vessels in the body will help stop the growth and the spread of cancer. The other two chemotherapy drugs, gemcitabine and carboplatin, are currently being used together for the treatment of ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/carboplatin/bevacizumab | Experimental | Drug: Bevacizumab, Drug: Gemcitabine, Drug: CarboplatinA regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cancer of the ovaries, fallopian tube or abdominal lining has come back after more than 6 months from the last platinum based chemotherapy treatment.
- Disease must be detected by CT or CA125 level must be elevated or cancerous ascites must be present.
- History of at least one therapy of platinum based chemotherapy.
Key exclusion criteria (14 listed)
- Participation in another experimental drug study
- Heart disease or high blood pressure
- History of a stroke within the past 6 months
- Vascular disease, or bleeding problems
- Brain cancer
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 |
|---|---|---|
| BevacizumabAlso: Avastin®Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle. | Drug | Gemcitabine/carboplatin/bevacizumab |
| GemcitabineA regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle | Drug | Gemcitabine/carboplatin/bevacizumab |
| Carboplatin | Drug | Gemcitabine/carboplatin/bevacizumab |
Primary outcome
Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding.
Time frame: up to 6 months
Progression-free survival (PFS) by RECIST, and safety. RECIST verison 1.0 was used for the assessment of progression and was based on radiologic evaluation.
1 secondary outcome
Overall Survival for Patients Treated With the Regimen.
Time frame: To progression of Disease
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18829088Richardson DL, Backes FJ, Seamon LG, Zanagnolo V, O'Malley DM, Cohn DE, Fowler JM, Copeland LJ. Combination gemcitabine, platinum, and bevacizumab for the treatment of recurrent ovarian cancer. Gynecol Oncol. 2008 Dec;111(3):461-6. doi: 10.1016/j.ygyno.2008.08.011. Epub 2008 Sep 30.
- JameslineLink 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.
Larry J. Copeland, MD principal investigator
Professor & Chair Department of Obstetrics & Gynecology and Division of Gynecologic Oncology
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 Bevacizumab, Gemcitabine and Carboplatin in people with Ovarian Cancer and Fallopian Tube Cancer, run by Ohio State University Comprehensive Cancer Center 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?
The sponsor lists 3 inclusion and 14 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 30 Apr 2015. 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?
Yes. Results are posted in the registry (first posted 30 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Determine the Antitumor Activity of Gemcitabine/Carboplatin/Bevacizumab Regimen as Measured by the Probability of Surviving Progression-free for at Least 6 Months or Responding. (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00267696, 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 30 Apr 2015.