Study of Intraperitoneal Carboplatin With IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01220154
Recruitment Status : Active, not recruiting
First Posted : October 13, 2010
Last Update Posted : October 14, 2016
Genentech, Inc.
Information provided by (Responsible Party):
David O'Malley, Ohio State University Comprehensive Cancer Center

Brief Summary:
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 or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer No Prior Chemotherapy Drug: Paclitaxel Drug: Carboplatin Drug: Bevacizumab Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2010
Estimated Primary Completion Date : March 2021

Arm Intervention/treatment
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:
  • Abraxane
  • Taxol
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01220154

United States, Ohio
OSU Gyn Oncology at Mill Run
Hilliard, Ohio, United States, 43026
Sponsors and Collaborators
David O'Malley
Genentech, Inc.
Principal Investigator: David O'Malley, MD Ohio State University Comprehensive Cancer Center

Additional Information:
Responsible Party: David O'Malley, Principal Investigator, Ohio State University Comprehensive Cancer Center Identifier: NCT01220154     History of Changes
Other Study ID Numbers: OSU-09115
NCI-2012-00341 ( Registry Identifier: Clinical Trials Reporting Program (CTRP) )
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

Keywords provided by David O'Malley, Ohio State University Comprehensive Cancer Center:
fallopian tube

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors