- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01220154
Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer
Phase I Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel and Bevacizumab in Patients With Previously Untreated Epithelial Ovarian Carcinoma or Primary Peritoneal Carcinoma
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ohio
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Hilliard, Ohio, United States, 43026
- OSU Gyn Oncology at Mill Run
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Carboplatin Paclitaxel & Bevacizumab
Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab
|
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:
Intraperitoneal Day 1 cycles 1-6 AUC
Other Names:
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose
Time Frame: Every Cycle-28 days
|
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.
|
Every Cycle-28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response Rate, Progression Free Survival and Overall Survival
Time Frame: Every 3 monthes for 2 years, Every 6 months for 3 years.
|
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. |
Every 3 monthes for 2 years, Every 6 months for 3 years.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David O'Malley, MD, Ohio State University Comprehensive Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Carboplatin
- Paclitaxel
- Bevacizumab
Other Study ID Numbers
- OSU-09115
- NCI-2012-00341 (Registry Identifier: Clinical Trials Reporting Program (CTRP))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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