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

Part of paid clinical trials in Hilliard, Ohio.

Sponsor
David O'Malley
Study ID
NCT01220154
Phase
PHASE1
Status
Completed

Conditions

  • Fallopian Tube Cancer
  • No Prior Chemotherapy
  • Ovarian Cancer
  • Primary Peritoneal Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Paclitaxel — DRUG
    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.
  • Carboplatin — DRUG
    Intraperitoneal Day 1 cycles 1-6 AUC
  • Bevacizumab — DRUG
    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

Study Details

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.

Key Dates

First listed
Oct 13, 2010
Start date
Apr 28, 2011
Status verified
Dec 2024
Primary completion
Jul 17, 2023
Completion
Jul 17, 2023

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin Paclitaxel & Bevacizumab
    Intraperitoneal carboplatin with weekly intravenous paclitaxel and intravenous bevacizumab

Primary Outcome Measure

Maximum Tolerated Dose [ Time Frame: Every Cycle-28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
OSU Gyn Oncology at Mill RunHilliardOhio43026-

Find similar trials in Hilliard, OH

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
OSU Gyn Oncology at Mill Run· Hilliard, OH

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