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

Primary Purpose

Gynecologic Malignancies

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Paclitaxel

Carboplatin

About this trial

This is an interventional treatment trial for Gynecologic Malignancies focused on measuring chemotherapy dosing, Body surface area, BSA, paclitaxel, carboplatin, dose dense

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paclitaxel + Carboplatin

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02756013

First Posted

April 28, 2016

Last Updated

June 29, 2022

Sponsor

Case Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT02756013

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Terminated

Why Stopped

Lack of accrual - terminated

Study Start Date

April 20, 2016 (Actual)

Primary Completion Date

August 16, 2018 (Actual)

Study Completion Date

January 24, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gynecologic Malignancies

Keywords

chemotherapy dosing, Body surface area, BSA, paclitaxel, carboplatin, dose dense

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paclitaxel + Carboplatin

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Taxol

Intervention Description

80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Paraplatin, Paraplatin - aqueous solution (AQ)

Intervention Description

area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles

Primary Outcome Measure Information:

Title

Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed

Description

Time Frame

Up to 190 days

Secondary Outcome Measure Information:

Title

Number of Participants With Progression-free Survival (PFS)

Description

Time Frame

every 3 months for up to 2 years, then every 6 months (up to 31 months)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Rose, MD

Organizational Affiliation

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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