Clinical trial NCT02756013: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Gynecologic Malignancies
Keywords: chemotherapy dosing
Body surface area
BSA
paclitaxel
carboplatin
dose dense
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed
timeFrame: Up to 190 days
Secondary outcomes:
measure: Number of Participants With Progression-free Survival (PFS)
timeFrame: every 3 months for up to 2 years, then every 6 months (up to 31 months)
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
name: Peter Rose, MD
role: PRINCIPAL_INVESTIGATOR
References: