Ovarian NeoplasmsPhase 2NCT00127920
Pilot Study of Taxol, Carboplatin, and Bevacizumab in Advanced Stage Ovarian Carcinoma Patients
A Phase 2 study testing Avastin in people with Ovarian Neoplasms, run by Gynecologic Oncology Associates at 2 sites in United States.
Trial summary
The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy (Morrow \& Curtin, 1998). This involves an optimal primary tumor debulking surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Avastin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to Oct 2012
- 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
- Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.
- Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.
- If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.
- Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC > 3,000 cells/cu ml., platelets > 100,000/cu.ml., calculated creatinine clearance > 50 ccs/min., bilirubin < 1.5 mg/dl, and SGOT < three times normal.
- Karnofsky performance status > 50%.
- Subjects who have signed an institutional review board (IRB) approved informed consent form.
Who cannot join
- Subjects with epithelial ovarian cancer of low malignancy potential.
- Subjects with septicemia, severe infection, or acute hepatitis.
- Subjects with severe gastrointestinal bleeding.
- Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gynecologic Oncology Associates
Newport Beach, California, 92663
Florida Hospital College of Health Sciences
Orlando, Florida, 32803
About this study
Official title: A Phase II, Open-Label, Non-Randomized, Multi-Center Pilot Study of Intravenous Taxol, Carboplatin, Bevacizumab Given Every 21 Days in Patients With Newly Diagnosed Stage III/IV Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy (Morrow \& Curtin, 1998). This involves an optimal primary tumor debulking surgery. The most active chemotherapy agents should then be promptly administered. Taxol and Carboplatin or Cisplatin have become the standard" first line" therapy because of proven survival benefits with those regimens in treating advanced ovarian adenocarcinoma patients. New chemotherapy agents like bevacizumab have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients and are being studied for their potential contributory impact on the current standard of treatment. Since no triplet regimen has demonstrated compelling superiority, the combination of taxol, carboplatin, and bevacizumab is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.
The null hypothesis (Ho) is that the drug regimen will demonstrate an 80% patient response rate (RR).
Read more
The alternative Hypothesis (H1): The triplet drug regimen will demonstrate a significantly higher patient response rate than standard therapy.
Hypothesis (H2): The triplet drug regimen will demonstrate a significantly more favorable patient time to tumor progression rate than standard therapy.
Read the detailed description
The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy. This involves an optimal primary tumor debulking surgery. The most active chemotherapy agents should then be promptly administered. Taxol and Carboplatin or Cisplatin have become the standard" first line" therapy because of proven survival benefits with those regimens in treating advanced ovarian adenocarcinoma patients. New agents like bevacizumab (Avastin), which have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients, are being added to the optimal first line ovarian chemotherapy regimen in hopes of seeing improvement in progressive free interval and over-all survival. Since no triplet regimen has demonstrated compelling superiority, the combination of taxol, carboplatin, and bevacizumab (Avastin) is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.
- Conditions
- Ovarian Neoplasms
- Being tested
- Avastin
- 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
Paclitaxel, Carboplatin and Avastin given on day 1 every 21 days
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Paclitaxel, Carboplatin and Avastin on day1 every 21 days Receives: Drug: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to tumor progression
response rate
Secondary outcomes (2)
safety
survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startAug 2004
- Primary completionAug 2006
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- John P Micha, MD, Principal investigator, Gynecologic Oncology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127920
- Sponsor's protocol ID
- AV53206s
- Status last verified
- Mar 2015
- First submitted
- 5 Aug 2005
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Non-Randomized, Multi-Center Pilot Study of Intravenous Taxol, Carboplatin, Bevacizumab Given Every 21 Days in Patients With Newly Diagnosed Stage III/IV Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT00127920
- Acronym / sponsor ID
- AV53206s
- Conditions
- Ovarian Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Gynecologic Oncology AssociatesUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Aug 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 9 Aug 2005 (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.
The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy (Morrow \& Curtin, 1998). This involves an optimal primary tumor debulking surgery. The most active chemotherapy agents should then be promptly administered. Taxol and Carboplatin or Cisplatin have become the standard" first line" therapy because of proven survival benefits with those regimens in treating advanced ovarian adenocarcinoma patients. New chemotherapy agents like bevacizumab have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients and are being studied for their potential contributory impact on the current standard of treatment. Since no triplet regimen has demonstrated compelling superiority, the combination of taxol, carboplatin, and bevacizumab is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.
The null hypothesis (Ho) is that the drug regimen will demonstrate an 80% patient response rate (RR).
The alternative Hypothesis (H1): The triplet drug regimen will demonstrate a significantly higher patient response rate than standard therapy.
Hypothesis (H2): The triplet drug regimen will demonstrate a significantly more favorable patient time to tumor progression rate than standard therapy.
Detailed description
The most likely way to improve survival and cure rates in treating ovarian cancer, fallopian tube epithelial cancer, and peritoneal cancer is with maximal "upfront" therapy. This involves an optimal primary tumor debulking surgery. The most active chemotherapy agents should then be promptly administered. Taxol and Carboplatin or Cisplatin have become the standard" first line" therapy because of proven survival benefits with those regimens in treating advanced ovarian adenocarcinoma patients. New agents like bevacizumab (Avastin), which have demonstrated increased overall and progression free survival benefits in metastatic colorectal cancer patients, are being added to the optimal first line ovarian chemotherapy regimen in hopes of seeing improvement in progressive free interval and over-all survival. Since no triplet regimen has demonstrated compelling superiority, the combination of taxol, carboplatin, and bevacizumab (Avastin) is intriguing because of their potential synergy, distinct mechanisms of action, and non-overlapping toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: AvastinPaclitaxel, Carboplatin and Avastin on day1 every 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with a histologic or cytologic diagnosis of stage III/IV ovarian cancer, fallopian tube epithelial cancer, or peritoneal cancer who have not received prior chemotherapy or radiotherapy.
- Subjects must have the appropriate surgery for their gynecologic cancer. However, subjects may be treated in a neoadjuvant manner, with surgery being performed after chemotherapy cycles 1, 2, or 3.
- If neoadjuvant therapy is not administered, subjects must receive their first dose no more than six weeks postoperatively.
- Subjects must have adequate bone marrow, renal and hepatic function as defined by WBC > 3,000 cells/cu ml., platelets > 100,000/cu.ml., calculated creatinine clearance > 50 ccs/min., bilirubin < 1.5 mg/dl, and SGOT < three times normal.
- Karnofsky performance status > 50%.
Key exclusion criteria (4 listed)
- Subjects with epithelial ovarian cancer of low malignancy potential.
- Subjects with septicemia, severe infection, or acute hepatitis.
- Subjects with severe gastrointestinal bleeding.
- Subjects with a history of congestive heart failure, angina, or a history of myocardial infarction within the past six months.
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: BevacizumabPaclitaxel, Carboplatin and Avastin given on day 1 every 21 days | Drug | Single Arm |
Primary outcome
time to tumor progression
response rate
2 secondary outcomes
safety
survival
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 10 Mar 2015.
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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.
John P Micha, MD principal investigator
Gynecologic Oncology Associates
2 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 Avastin in people with Ovarian Neoplasms, run by Gynecologic Oncology Associates at 2 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?
The sponsor lists 6 inclusion and 4 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 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does the primary outcome measure?
time to tumor progression. The study lists 2 primary outcomes in all. 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 10 Mar 2015.