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

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Terminated; Phase 2

Conditions: Gynecologic Malignancies

Treatments: Drug: Paclitaxel; Drug: Carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02756013

CASE13815

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

3 participants in 1 patient group

Paclitaxel + Carboplatin

Experimental group

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.

Treatment:

Drug: Carboplatin

Drug: Paclitaxel