NCT02756013

Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients w/ Body Surface Area (BSA) > 2.0

A Phase II Trial of Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients With a BSA > 2.0

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the side effects and effectiveness of giving standard paclitaxel chemotherapy in doses based on actual body surface area in combination with standard dosed carboplatin chemotherapy for overweight women.

Detailed description

Primary Objective The primary objective is to prospectively evaluate the Relative Dose Intensity (RDI) and toxicity of weight-based dose dense weekly paclitaxel and carboplatin in overweight patients with a BSA \> 2.0 compared to the Japanese Gynecologic Oncology Group trial (JGOG 2016) during 6 - 9 cycles of chemotherapy. Secondary Objective(s) The secondary objective is to evaluate progression-free survival in this patient population. Study Design This is a descriptive study to determine what the relative dose intensity of patients who are overweight with a BSA of greater than 2.0 can achieve.

Conditions

• Gynecologic Malignancies

Interventions

Type	Name	Description
DRUG	Paclitaxel	80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
DRUG	Carboplatin	area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles

Timeline

• Start date: 2016-04-20
• Primary completion: 2018-08-16
• Completion: 2019-01-24
• First posted: 2016-04-29
• Last updated: 2022-06-30
• Results posted: 2020-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study