Advanced Ovarian CarcinomaPhase 2NCT00511992
Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
A Phase 2 study testing Avastin, Paclitaxel and Cisplatin in people with Advanced Ovarian Carcinoma and Primary Peritoneal Carcinoma, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Ovarian Carcinoma, Primary Peritoneal Carcinoma, Ovarian Carcinosarcoma
- What is being tested?
- Avastin, Paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to 3 Aug 2015
- 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
- Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma.
- Adequate bone marrow, renal, and hepatic function
- Patients must be entered no more than twelve weeks postoperatively
Who cannot join
- Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
- Stage IV or suboptimally debulked disease following primary cytoreductive surgery
- Patients who have received prior radiotherapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Phase II Study of Paclitaxel (TAXOL), Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer
The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.
Read the detailed description
Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.
Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.
- Being tested
- Avastin, Paclitaxel, Cisplatin
- Keywords
- Ovarian Cancer, Gynecologic Cancer, Ovarian Carcinoma, Peritoneal Carcinoma, IP chemotherapy, Intraperitoneal, Avastin, Bevacizumab
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvastinDrug
Also called Bevacizumab
Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)
Consolidation Treatment:
Avastin 15mg/kg IV every 21 days x 12 cycles
PaclitaxelDrug
Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles
CisplatinDrug
75mg/m2 IP day 2 every 21 days x 6 cycles
| Study group | Role | What they receive |
|---|---|---|
| Avastin | Experimental | Not described Receives: Drug: Avastin; Drug: Paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Able to Complete 6 Cycles of Treatment.
Completion of cycle 6
Measured: 2 years
Secondary outcomes (1)
Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.
CTCAE assessment of toxicity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startJul 2007
- Primary completion3 Aug 2015
- Study completion3 Aug 2015
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.
- Other trials for Advanced Ovarian CarcinomaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- D. Scott McMeekin, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511992
- Sponsor's protocol ID
- 2674
- Status last verified
- Jun 2017
- First submitted
- 3 Aug 2007
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Paclitaxel (TAXOL), Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT00511992
- Acronym / sponsor ID
- 2674
- Keywords
- Ovarian Cancer, Gynecologic Cancer, Ovarian Carcinoma, Peritoneal Carcinoma, IP chemotherapy, Intraperitoneal, Avastin, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2007
- Primary completion
- 3 Aug 2015 (actual)
- Study completion
- 3 Aug 2015 (actual)
- First posted
- 6 Aug 2007 (estimated)
- Results
- Posted 2 Jul 2017
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 evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.
Detailed description
Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.
Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avastin | Experimental | Drug: Avastin, Drug: Paclitaxel, Drug: Cisplatin |
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)
- Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma.
- Adequate bone marrow, renal, and hepatic function
- Patients must be entered no more than twelve weeks postoperatively
Key exclusion criteria (3 listed)
- Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
- Stage IV or suboptimally debulked disease following primary cytoreductive surgery
- Patients who have received prior radiotherapy or chemotherapy.
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 |
|---|---|---|
| AvastinAlso: BevacizumabInitial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2) Consolidation Treatment: Avastin 15mg/kg IV every 21 days x 12 cycles | Drug | Avastin |
| PaclitaxelPaclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles | Drug | Avastin |
| Cisplatin75mg/m2 IP day 2 every 21 days x 6 cycles | Drug | Avastin |
Primary outcome
Number of Patients Able to Complete 6 Cycles of Treatment.
Time frame: 2 years
Completion of cycle 6
1 secondary outcome
Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
D. Scott McMeekin, MD principal investigator
University of Oklahoma
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 Avastin, Paclitaxel and Cisplatin in people with Advanced Ovarian Carcinoma and Primary Peritoneal Carcinoma, run by University of Oklahoma 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 3 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 2 Jul 2017. 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 2 Jul 2017). 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?
Number of Patients Able to Complete 6 Cycles of Treatment. (time frame: 2 years). 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 2 Jul 2017.