Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
David O'Malley
Collaborator:
Genentech
Information provided by (Responsible Party):
David O'Malley, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01220154
First received: October 12, 2010
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
Phase I study to evaluate intraperitoneal carboplatin along with weekly intravenous paclitaxel and bevacizumab in order to establish a tolerable dose and define the toxicity of this regimen in previously untreated patients with advanced ovarian carcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer No Prior Chemotherapy |
Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel and Bevacizumab in Patients With Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma |
Resource links provided by NLM:
Further study details as provided by Ohio State University Comprehensive Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated Dose [ Time Frame: Every Cycle-28 days ] [ Designated as safety issue: Yes ]The Maximum Tolerated Dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity.
Secondary Outcome Measures:
- Response Rate, Progression Free Survival and Overall Survival [ Time Frame: Every 3 monthes for 2 years, Every 6 months for 3 years. ] [ Designated as safety issue: No ]
Response Rate in patients with measurable disease using the RECIST(Response Evaluation Criteria in Solid Tumors)criteria.
Progression free survival is also uses the RECIST criteria or GCIG criteria. Overall survival will be followed for 5 years.
| Estimated Enrollment: | 24 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | October 2020 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Carboplatin Paclitaxel & Bevacizumab
Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab
|
Drug: Paclitaxel
Cycle 1 Day 1, 8, 15 IV 60-80mg mg/m2 as a 1 hour infusion. For cycle 2-6 Day 1,8,15 IV 60-80 mg/m2 as 1 hour infusion. Repeat every 3 weeks times 5 cycles.
Other Names:
Drug: Carboplatin
Intraperitoneal Day 1 cycles 1-6 AUC
Other Name: Paraplatin®
Drug: Bevacizumab
Bevacizumab 15 mg/kg intravenous infusion Day 1 cycles 2-6 Optional cycles 7-22 15 mg/kg intravenous infusion Day 1 every 21 days
Other Name: Avastin
|
Detailed Description:
Phase I study with the primary objective to determine the maximum tolerated dose of intraperitoneal carboplatin and intravenous weekly paclitaxel given in combination with intravenous bevacizumab during the second two cycles of treatment in patients with chemo-naive epithelial ovarian, primary peritoneal or fallopian tube cancer. The maximum tolerated dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity during the second two cycles of treatment. Secondary objectives are to determine response rates and to estimate progression free survival and overall survival of this class of patients.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Histology diagnoses epithelial ovarian, primary peritoneal, or fallopian tube(Stage II, III or IV)either optimal or suboptimal after initial surgery.
- All patients must have had appropriate surgery for ovarian, peritoneal, or fallopian tube carcinoma with tissue available for histologic evaluation
- Histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant brenner tumor, adenocarcinoma NOS.
- GOG(Gynecologic Oncology Group)performance status of 0,1,2
- Entered within 12 weeks of most recent surgery performed for diagnosis.
- Patients must have adequate bone marrow function, renal function,hepatic function, neurologic function, blood coagulation parameters within normal limits
- Sign approved consent form.
Exclusion Criteria:
- Patients who have received prior treatment other than initial surgery
- Patients who have received prior radiotherapy to any portion of their abdominal cavity or pelvis
- Patients with acute hepatitis or active infection
- Patients with active bleeding
- Patients with unstable angina
- Patients with history of invasive malignancies with the exception of nonmelanoma skin cancer and localized breast cancer.
- Patients who have received any target therapy or hormonal therapy for management of their ovarian cancer.
- Patients with synchronous primary endometrial cancer.
- Patients with epithelial tumors of low malignant potential
- Serious non healing wound, ulcer or bone fracture.
- Patients with history or evidence of CNS(central nervous system disease)
- Patients under 18 years old.
- Patients who have received prior therapy with anti-VEGF(vascular endothelial growth factor)
drug, bevacizumab
- Patients who have a history of allergic reaction to polysorbate 80.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220154
Locations
| United States, Ohio | |
| OSU Gyn Oncology at Mill Run | |
| Hilliard, Ohio, United States, 43026 | |
Sponsors and Collaborators
David O'Malley
Genentech
Investigators
| Principal Investigator: | David O'Malley, MD | Ohio State University |
More Information
Additional Information:
No publications provided
| Responsible Party: | David O'Malley, Principal Investigator, Ohio State University Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01220154 History of Changes |
| Other Study ID Numbers: | OSU-09115, NCI-2012-00341 |
| Study First Received: | October 12, 2010 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ohio State University Comprehensive Cancer Center:
|
ovarian cancer fallopian tube peritoneal intraperitoneal |
bevacizumab carboplatin paclitaxel chemo-naive |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Fallopian Tube Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms |
Digestive System Diseases Peritoneal Diseases Fallopian Tube Diseases Bevacizumab Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Angiogenesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013