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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
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
  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:
  • 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Inc.
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:
Fallopian Tube Neoplasms
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Fallopian Tube Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Bevacizumab
Carboplatin
Paclitaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Growth Inhibitors
Growth Substances
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014