Ovarian CancerPhase 2NCT01821859
Abraxane/Bevacizumab
A Phase 2 study testing Abraxane and Bevacizumab in people with Ovarian Cancer and Peritoneal Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
The protocol will study the effect of the combination of two drugs-Abraxane and Bevacizumab-on a subject's ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. This study drug combination will be given to subjects who have already been treated for their cancer with other chemotherapy, and now their… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Peritoneal Cancer
- What is being tested?
- Abraxane and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Nov 2011
- 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 must have histologically or cytologically confirmed recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via the pathology report.
- All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be >20mm when measured by conventional techniques including CT, and MRI, or >10 mm when measured by spiral CT.
- Patients must have at least one "target lesion" to be used to assess response as defined by RECIST. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
- Patients are required to receive at least one additional cytotoxic regimen for management of recurrent or persistent disease. Patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy either alone or as part of the cytotoxic regimens for management of recurrent or persistent disease.
- Age >18 years. Women all races and ethnic groups will be included.
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- Patients with an ECOG performance status < 2. ( see APPENDIX A)
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count >1,500/uL
- platelets >100,000/uL
- hemoglobin >9 g/dL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) <2.5 X institutional upper limit of normal
- Alkaline Phosphatase within normal institutional limits
- creatinine <1.5 X institutional upper limit of normal
- Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE v4.0 grade 2. (see APPENDIX B)
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had chemotherapy or radiotherapy within 28 days prior to entering the study or whose adverse events due to agents administered more than 28 days earlier continue to be grade 3 or greater.
- Patients may not have received any other investigational agents within the past 28 days.
- Any hormonal therapy or immunotherapy directed at the malignant tumor must be discontinued at least one week prior to enrollment. Continuation of hormone replacement therapy is permitted. Continuation of other established medical treatments for a known medical condition is permitted.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Abraxane or Bevacizumab.
- Patients who have had prior therapy with Abraxane.
- Patients who have received radiation to more than 25% of marrow-bearing areas. (see APPENDIX C)
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- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years.
- Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last five years are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than five years prior to registration, and the patient remains free of recurrent or metastatic disease.
- Patients who have known active liver disease or hepatitis.
- Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels.
- Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment on this study.
- Patients with clinically significant cardiovascular disease, including:
- uncontrolled hypertension, myocardial infarction, unstable angina within 6 months of enrollment, NYHA Grade II or greater heart failure, serious cardiac arrhythmia requiring medication, grade II or greater peripheral vascular disease.
- Patients with clinically significant proteinuria. Patients with a urine protein of 1+ on dipstick should undergo a 24-hour urine collection, which must demonstrate < 100 mg protein/24 hr to allow participation in the study.
- Patients with known hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.
- Patients who have a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment on the study, or anticipation of need for major surgical procedure during the course of the study.
- Patients who have received commercial bevacizumab within 28 days prior to enrollment on the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection(with the exception of uncomplicated UTI), chronic non- healing wound, bone fracture, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant or lactating women are excluded from this study because of possible risk to the fetus or infant.
- Known HIV-positive patients are excluded from the study because of possible risk of lethal infection when treated with marrow suppressive therapy.
- Safety data regarding Abraxane use in patients with ascites is not available; therefore patients with symptomatic ascites will be excluded from participation in the study. Patients may have asymptomatic ascites.
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: A Phase II Evaluation of Abraxane Plus Bevacizumab for the Treatment of Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
The protocol will study the effect of the combination of two drugs-Abraxane and Bevacizumab-on a subject's ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. This study drug combination will be given to subjects who have already been treated for their cancer with other chemotherapy, and now their cancer has become worse or has come back again. Neither one of these study drugs has been approved by the FDA for treatment in these three types of cancer.
- Conditions
- Ovarian Cancer, Peritoneal Cancer
- Being tested
- Abraxane, 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.
AbraxaneDrug
Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.
BevacizumabDrug
Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
| Study group | Role | What they receive |
|---|---|---|
| Abraxane/Bevacizumab | Experimental | Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion. Receives: Drug: Abraxane; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression Free Survival Rate at 6 Months as Defined as Complete Response, Partial Response, or Stable Disease.
Using RECIST criteria, Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease.
Measured: 6 months after start of dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startJan 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Terminated due to low enrollment
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 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tanja Pejovic, MD, PhD, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821859
- Sponsor's protocol ID
- IRB00005859
- Status last verified
- Jul 2013
- First submitted
- 27 Mar 2013
- Last updated
- 26 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Evaluation of Abraxane Plus Bevacizumab for the Treatment of Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT01821859
- Acronym / sponsor ID
- IRB00005859
- Conditions
- Ovarian Cancer, Peritoneal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Posted 16 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The protocol will study the effect of the combination of two drugs-Abraxane and Bevacizumab-on a subject's ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. This study drug combination will be given to subjects who have already been treated for their cancer with other chemotherapy, and now their cancer has become worse or has come back again. Neither one of these study drugs has been approved by the FDA for treatment in these three types of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abraxane/Bevacizumab | Experimental | Drug: Abraxane, Drug: BevacizumabBevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion. Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients must have histologically or cytologically confirmed recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma. Histologic documentation of the original primary tumor is required via the pathology report.
- All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be >20mm when measured by conventional techniques including CT, and MRI, or >10 mm when measured by spiral CT.
- Patients must have at least one "target lesion" to be used to assess response as defined by RECIST. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
- Patients must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound. This initial treatment may have included intraperitoneal therapy, high-dose therapy, consolidation, non-cytotoxic agents or extended therapy administered after surgical or non-surgical assessment.
- Patients are required to receive at least one additional cytotoxic regimen for management of recurrent or persistent disease. Patients are allowed to receive, but are not required to receive, biologic (non-cytotoxic) therapy either alone or as part of the cytotoxic regimens for management of recurrent or persistent disease.
Key exclusion criteria (21 listed)
- Patients who have had chemotherapy or radiotherapy within 28 days prior to entering the study or whose adverse events due to agents administered more than 28 days earlier continue to be grade 3 or greater.
- Patients may not have received any other investigational agents within the past 28 days.
- Any hormonal therapy or immunotherapy directed at the malignant tumor must be discontinued at least one week prior to enrollment. Continuation of hormone replacement therapy is permitted. Continuation of other established medical treatments for a known medical condition is permitted.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Abraxane or Bevacizumab.
- Patients who have had prior therapy with Abraxane.
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 |
|---|---|---|
| AbraxaneAbraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion. | Drug | Abraxane/Bevacizumab |
| BevacizumabBevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion. | Drug | Abraxane/Bevacizumab |
Primary outcome
Number of Participants With Progression Free Survival Rate at 6 Months as Defined as Complete Response, Partial Response, or Stable Disease.
Time frame: 6 months after start of dosing
Using RECIST criteria, Complete Response (CR)= disappearance of all target lesions, Partial Response (PR)= At least a 30% decrease in the sum of the longest diameter of target lesions, and Stable Disease (SD)= neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify as progressive disease.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2013.
- 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.
Tanja Pejovic, MD, PhD principal investigator
OHSU Knight Cancer Institute
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 Abraxane and Bevacizumab in people with Ovarian Cancer and Peritoneal Cancer, run by OHSU Knight Cancer Institute 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 17 inclusion and 21 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: stopped early, as of the sponsor's last update on 26 Jul 2013. 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 16 May 2013). 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 Participants With Progression Free Survival Rate at 6 Months as Defined as Complete Response, Partial Response, or Stable Disease. (time frame: 6 months after start of dosing). 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 26 Jul 2013.