Ovarian NeoplasmsPhase 2NCT00698451
A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
A Phase 2 study testing doxorubicin HCL liposome; bevacizumab; carboplatin in people with Ovarian Neoplasms and Fallopian Tube Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
- What is being tested?
- doxorubicin HCL liposome; bevacizumab; carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 2010
- 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
- Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer
- Relapse-free interval of >6 months afer completion of first line platinum-based chemotherapy
- Measurable disease (at least one lesion that can be accurately measured in a least 1 dimension)
- Adequate bone marrow function, renal, and liver function. Normal cardiac function
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Who cannot join
- No patients who have received more than 1 previous regimen of chemotherapy (maintenance is not considered a second regimen)
- No patients receiving immunotherapy or radiotherapy or patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis
- No patients who require parenteral hydration or nutrition or have clinical signs or symptoms of gastrointestinal bowel obstruction or perforation
- No patients with previous or current malignancy other than basal cell or squamous cell carcinoma of the skin
- No patients with clinically significant cardiovascular disease
- No patients with a history of bevacizumab or other VEGF or VEGF receptor-targeted agent use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Single Arm Study of Carboplatin and DOXIL (PLD) Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
The purpose of this study is to evaluate the response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.
Read the detailed description
DOXIL pegylated liposomal doxorubicin (PLD) is approved for use in patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. Data suggest that combination therapy of carboplatin plus DOXIL provides superior benefit to single agent therapy. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, is approved for use in combination with intravenous 5-fluorouracil-based chemotherapy for the treatment of metastatic colorectal cancer and in combination with carboplatin and paclitaxel (treatment of non-small cell lung cancer); and with paclitaxel (first line treatment of metastatic HER2-negative breast cancer). There are data showing bevacizumab has activity in the treatment of ovarian cancer, and it is currently being studied in platinum-sensitive relapsed ovarian cancer in combination with carboplatin/gemcitabine. No data exist on the efficacy and safety of bevacizumab administered with carboplatin and DOXIL. Based on the growing interest of incorporating bevacizumab in to ovarian cancer treatment and the activity seen to date, the evaluation of the combination of carboplatin and DOXIL with bevacizumab is warranted. This is a single arm (one dosing regimen), multicenter, open label (both the patient and the physician know what drug is being given) study in patients with platinum-sensitive recurrent ovarian, fallopian tube or primary peritoneal cancers. This study will be conducted in multiple sites across the United States. All patients will receive DOXIL, carboplatin and bevacizumab by intravenous (IV) infusion for a maximum of ten (10) 28-day cycles. A disease response assessment will occur after the completion of Cycles 2, 4, 6, 8 and at the end of treatment. Patients will be followed for six (6) months post-treatment for progression-free survival. Disease progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST). RECIST is an accepted classification for response to treatment with classifications of Complete Response (CR), Partial Response( (PR), Progressive Disease (PD) or Stable Disease (SD).The primary objective of this study is to evaluate the objective response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. The secondary objectives are to assess the safety profile of carboplatin and DOXIL in combination with bevacizumab as well as the following efficacy endpoints: Duration of response, Progression-free Survival, and Time to Progression. Safety will be evaluated using adverse events, clinical laboratory tests, and tests for cardiac function after the first 20 patients have been entered and received at least 2 cycles of therapy. Overall safety will be summarized at study completion. DOXIL (30 mg/m2), and carboplatin (area under the curve (AUC 5)) will be given on Day 1 of each 28-day cycle. Bevacizumab (10 mg/kg) will be given on days 1 and 15 of every 28-day cycle. All treatment will be given by intravenous (IV) infusion and repeated every 4 weeks for up to 10 cycles.
- Being tested
- doxorubicin HCL liposome; bevacizumab; carboplatin
- Keywords
- Ovarian cancer, fallopian tube cancer, primary peritoneal cancer, DOXIL, carboplatin, bevacizumab
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxorubicin HCL liposome; bevacizumab; carboplatinDrug
30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle Receives: Drug: doxorubicin HCL liposome; bevacizumab; carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Efficacy End Point is the Number of Patients With an Objective Response.
Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Measured: Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)
Secondary outcomes (1)
The Secondary Efficacy Endpoints is Duration of Objective Response.
Objective Response Rate to Treatment Defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR) Where a Complete response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Duration of response: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.
Measured: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startAug 2008
- Primary completionOct 2010
- Study completionOct 2010
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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Responsible party
- Sponsor
- Investigators
- Tracey McGowan, MD, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00698451
- Sponsor's protocol ID
- CR015094
- Other IDs
- DOXILOVC2007
- Status last verified
- Aug 2013
- First submitted
- 12 Jun 2008
- Last updated
- 6 Sep 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Single Arm Study of Carboplatin and DOXIL (PLD) Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
- ClinicalTrials.gov ID
- NCT00698451
- Acronym / sponsor ID
- CR015094
- Keywords
- Ovarian cancer, fallopian tube cancer, primary peritoneal cancer, DOXIL, carboplatin, bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Study start
- Aug 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Posted 12 Jul 2013
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 response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. All patients will received DOXIL, carboplatin and bevacizumab for a maximum of ten 28-day cycles. Patients will be followed for six months following treatment to assess progression-free survival.
Detailed description
DOXIL pegylated liposomal doxorubicin (PLD) is approved for use in patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. Data suggest that combination therapy of carboplatin plus DOXIL provides superior benefit to single agent therapy. Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, is approved for use in combination with intravenous 5-fluorouracil-based chemotherapy for the treatment of metastatic colorectal cancer and in combination with carboplatin and paclitaxel (treatment of non-small cell lung cancer); and with paclitaxel (first line treatment of metastatic HER2-negative breast cancer). There are data showing bevacizumab has activity in the treatment of ovarian cancer, and it is currently being studied in platinum-sensitive relapsed ovarian cancer in combination with carboplatin/gemcitabine. No data exist on the efficacy and safety of bevacizumab administered with carboplatin and DOXIL. Based on the growing interest of incorporating bevacizumab in to ovarian cancer treatment and the activity seen to date, the evaluation of the combination of carboplatin and DOXIL with bevacizumab is warranted. This is a single arm (one dosing regimen), multicenter, open label (both the patient and the physician know what drug is being given) study in patients with platinum-sensitive recurrent ovarian, fallopian tube or primary peritoneal cancers. This study will be conducted in multiple sites across the United States. All patients will receive DOXIL, carboplatin and bevacizumab by intravenous (IV) infusion for a maximum of ten (10) 28-day cycles. A disease response assessment will occur after the completion of Cycles 2, 4, 6, 8 and at the end of treatment. Patients will be followed for six (6) months post-treatment for progression-free survival. Disease progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST). RECIST is an accepted classification for response to treatment with classifications of Complete Response (CR), Partial Response( (PR), Progressive Disease (PD) or Stable Disease (SD).The primary objective of this study is to evaluate the objective response rate (Complete Response (CR) and Partial Response (PR)) to carboplatin and DOXIL treatment in combination with bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube and primary peritoneal cancers. The secondary objectives are to assess the safety profile of carboplatin and DOXIL in combination with bevacizumab as well as the following efficacy endpoints: Duration of response, Progression-free Survival, and Time to Progression. Safety will be evaluated using adverse events, clinical laboratory tests, and tests for cardiac function after the first 20 patients have been entered and received at least 2 cycles of therapy. Overall safety will be summarized at study completion. DOXIL (30 mg/m2), and carboplatin (area under the curve (AUC 5)) will be given on Day 1 of each 28-day cycle. Bevacizumab (10 mg/kg) will be given on days 1 and 15 of every 28-day cycle. All treatment will be given by intravenous (IV) infusion and repeated every 4 weeks for up to 10 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: doxorubicin HCL liposome; bevacizumab; carboplatindoxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 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 (5 listed)
- Histologic diagnosis of epithelial ovarian, fallopian tube or primary peritoneal cancer
- Relapse-free interval of >6 months afer completion of first line platinum-based chemotherapy
- Measurable disease (at least one lesion that can be accurately measured in a least 1 dimension)
- Adequate bone marrow function, renal, and liver function. Normal cardiac function
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (6 listed)
- No patients who have received more than 1 previous regimen of chemotherapy (maintenance is not considered a second regimen)
- No patients receiving immunotherapy or radiotherapy or patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis
- No patients who require parenteral hydration or nutrition or have clinical signs or symptoms of gastrointestinal bowel obstruction or perforation
- No patients with previous or current malignancy other than basal cell or squamous cell carcinoma of the skin
- No patients with clinically significant cardiovascular disease
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 |
|---|---|---|
| doxorubicin HCL liposome; bevacizumab; carboplatin30 mg/m2 by intravenous infusion Day 1 of each 28 day cycle; 10 mg/kg by intravenous infusion Days 1 and 15 of each 28 day cycle; AUC=5 by intravenous infusion Day 1 of each 28 day cycle | Drug | 001 |
Primary outcome
The Primary Efficacy End Point is the Number of Patients With an Objective Response.
Time frame: Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)
Objective Response Rate to Treatment is defined as the Proportion of Patients With a Complete Response (CR) or Partial Response (PR). A Complete Response (CR) is the disappearance of all target lesions and a Partial Response is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
1 secondary outcome
The Secondary Efficacy Endpoints is Duration of Objective Response.
Time frame: Duration of response was defined only for subjects with CR or PR as the best overall response. It was calculated from the date of first documentation of response to the date of disease progression or death due to progressive disease.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 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.
Tracey McGowan, MD study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 doxorubicin HCL liposome; bevacizumab; carboplatin in people with Ovarian Neoplasms and Fallopian Tube Neoplasms, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 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 5 inclusion and 6 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 6 Sep 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 12 Jul 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?
The Primary Efficacy End Point is the Number of Patients With an Objective Response. (time frame: Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)). 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 6 Sep 2013.