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Sponsors and Collaborators: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Centocor Ortho Biotech Services, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00698451 |
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.
Condition | Intervention | Phase |
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Peritoneal Neoplasms Ovarian Neoplasms Fallopian Tube Neoplasms |
Drug: doxorubicin HCL liposome; bevacizumab; carboplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy 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 |
Estimated Enrollment: | 60 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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001: Experimental |
Drug: doxorubicin HCL liposome; 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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | info1@veritasmedicine.com |
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Ortho Biotech Products, L.P. ( Vice President Medical Affairs Oncolog/ Nephrology ) |
Study ID Numbers: | CR015094, DOXILOVC2007 |
Study First Received: | June 12, 2008 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00698451 History of Changes |
Health Authority: | United States: Food and Drug Administration |
fallopian tube cancer DOXIL bevacizumab |
primary peritoneal cancer Ovarian cancer carboplatin |
Fallopian Tube Cancer Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Bevacizumab Genital Diseases, Female Anti-Bacterial Agents Peritoneal Diseases Ovarian Cancer Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases Carboplatin Abdominal Neoplasms Angiogenesis Inhibitors Recurrence Fallopian Tube Neoplasms Doxorubicin Fallopian Tube Diseases Digestive System Diseases Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy |
Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Bevacizumab Antibiotics, Antineoplastic Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Growth Inhibitors Angiogenesis Modulating Agents Endocrine Gland Neoplasms Ovarian Neoplasms |
Digestive System Neoplasms Growth Substances Genital Neoplasms, Female Endocrine System Diseases Carboplatin Abdominal Neoplasms Angiogenesis Inhibitors Fallopian Tube Neoplasms Doxorubicin Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Peritoneal Neoplasms |