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

NCT ID: NCT02756013

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-20
• Study Completion Date: 2019-01-24

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.

Conditions

Gynecologic Malignancies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Paclitaxel

Intervention Type: DRUG

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

Carboplatin

Intervention Type: DRUG

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

Interventions

Paclitaxel

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

Intervention Type: DRUG

Carboplatin

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

Intervention Type: DRUG

Other Intervention Names

Taxol; Paraplatin; Paraplatin - aqueous solution (AQ)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Rose, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CASE13815

Identifier Type: -

Identifier Source: org_study_id