A Phase 2 interventional study of doxorubicin HCL liposome; bevacizumab; carboplatin in Ovarian Neoplasms, Fallopian Tube Neoplasms and Peritoneal Neoplasms, sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-06.
Sponsored by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
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.
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.
2,757 studies on the registry are indexed under Ovarian Neoplasms; 735 are open to participants now.
This study's enrollment of 54 is close to the median of 59 across 2,075 interventional studies indexed under Ovarian Neoplasms.
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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: doxorubicin HCL liposome; bevacizumab; carboplatin
Drug pages: Liposomal doxorubicin · Bevacizumab · Carboplatin
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
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
Time frame: Approximately 280 days (from start of treatment to the end of 10 cycles of treatment where each cycle is 28 days)
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.
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.
| Milestone | DOXIL/CARBOPLATIN/BEVACIZUMAB |
|---|---|
| Started | 54 |
| Completed | 15 |
| Not completed | 39 |
| Withdrew: Adverse event | 22 |
| Withdrew: Physician decision | 2 |
| Withdrew: Protocol violation | 6 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Disease progression | 3 |
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
| Participants | DOXIL/CARBOPLATIN/BEVACIZUMAB |
|---|---|
| The Primary Efficacy End Point is the Number of Patients With an Objective Response. | 39 |
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.
| Days | DOXIL/CARBOPLATIN/BEVACIZUMAB |
|---|---|
| The Secondary Efficacy Endpoints is Duration of Objective Response. | 362 (282 to NA) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DOXIL/CARBOPLATIN/BEVACIZUMAB | — | 15/54 (27.8%) | 53/54 (98.1%) |
| Event | DOXIL/CARBOPLATIN/BEVACIZUMAB |
|---|---|
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 2/54 |
| Deep Vein ThrombosisVascular disorders | 2/54 |
| ConstipationGastrointestinal disorders | 1/54 |
| Large Intestinal ObstructionGastrointestinal disorders | 1/54 |
| NauseaGastrointestinal disorders | 1/54 |
| Small Intestinal ObstructionGastrointestinal disorders | 1/54 |
| Small Intestinal PerforationGastrointestinal disorders | 1/54 |
| Abdominal AbscessInfections and infestations | 1/54 |
| BacteraemiaInfections and infestations | 1/54 |
| Staphylococcal InfectionInfections and infestations | 1/54 |
| Event | DOXIL/CARBOPLATIN/BEVACIZUMAB |
|---|---|
| FatigueGeneral disorders | 32/54 |
| NauseaGastrointestinal disorders | 31/54 |
| AnaemiaBlood and lymphatic system disorders | 28/54 |
| ThrombocytopeniaBlood and lymphatic system disorders | 28/54 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 28/54 |
| NeutropeniaBlood and lymphatic system disorders | 23/54 |
| HeadacheNervous system disorders | 23/54 |
| StomatitisGastrointestinal disorders | 20/54 |
| LeukopeniaBlood and lymphatic system disorders | 20/54 |
| HypertensionVascular disorders | 20/54 |
| Age, Categorical(Participants) | DOXIL/CARBOPLATIN/BEVACIZUMAB |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 32 |
| >=65 years | 22 |
| Age Continuous(years) | DOXIL/CARBOPLATIN/BEVACIZUMAB |
|---|---|
| Mean | 62.1 ± 9.00 |
| Sex: Female, Male(Participants) | DOXIL/CARBOPLATIN/BEVACIZUMAB |
|---|---|
| Female | 54 |
| Male | 0 |
| Region of Enrollment(participants) | DOXIL/CARBOPLATIN/BEVACIZUMAB |
|---|---|
| United States | 54 |
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Liposomal doxorubicin · Bevacizumab · Carboplatin
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