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

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.

Study Overview

• Status: Terminated
• Conditions: Gynecologic Malignancies
• Intervention / Treatment: Drug: Paclitaxel; Drug: Carboplatin

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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients with a histologically confirmed or presumed diagnosis of gynecologic malignancy for whom chemotherapy with paclitaxel and carboplatin is planned.
• Body Surface area >2.0

• Patients must have adequate:

  • Renal function: Creatinine <1.5 x Institutional upper limits of normal (ULN)

  • Bone marrow function:

    • Absolute neutrophil count (ANC) ≥ 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors.
    • Platelets ≥ 100,000/mcl.

  • Hepatic function:

    • Bilirubin ≤ 1.5 x ULN.
    • Aspartate aminotransferase (AST) (SGOT) ≤ 2.5 x ULN.
    • Alkaline phosphatase ≤ to 2.5 x ULN.

  • Neurologic function:

    • Neuropathy (sensory and motor) ≤ CTCAE Grade 1.
• Patients must have a Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.
• Patients must be entered within 12 weeks of diagnosis.
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
• Patients who have received prior chemotherapy.
• Patients with acute hepatitis or active infection that requires parenteral antibiotics.

• Patients with clinically significant cardiovascular disease. This includes:

  • Myocardial infarction or unstable angina < 6 months prior to registration.
  • New York Heart Association (NYHA) Grade II or greater congestive heart failure
  • Serious cardiac arrhythmia requiring medication. This does not include asymptomatic, atrial fibrillation with controlled ventricular rate.
• Patients who are pregnant or nursing.
• Patients with medical history or conditions not otherwise previously specified which in the opinion of the investigator should exclude participation in this study.
• Patients with known allergy to cremophor or polysorbate 80.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Paclitaxel + Carboplatin; Paclitaxel dosed by actual body surface area and not maxed at BSA 2.0. The Carboplatin dose will be calculated according to the Calvert formula using as estimated glomerular filtration rate from the Cockcroft-Gault formula and will be subject to maximum allowed doses.	Drug: Paclitaxel; 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles; Other Names: Taxol; Drug: Carboplatin; area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles; Other Names: Paraplatin; Paraplatin - aqueous solution (AQ)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed	Prospective evaluation of the Relative Dose Intensity (RDI) of weight-based dose dense weekly paclitaxel and carboplatin as measured by the average percent of completed treatment cycles out of the intended therapeutic plan	Up to 190 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Progression-free Survival (PFS)	Progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions	every 3 months for up to 2 years, then every 6 months (up to 31 months)

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Peter Rose, MD, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 20, 2016
• Primary Completion (ACTUAL): August 16, 2018
• Study Completion (ACTUAL): January 24, 2019

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (ESTIMATE): April 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: paclitaxel; carboplatin; BSA; chemotherapy dosing; Body surface area; dose dense
• Additional Relevant MeSH Terms: Body Weight; Overweight; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: CASE13815

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No