Gynecologic Malignancies
Conditions
Keywords
chemotherapy dosing, Body surface area, BSA, paclitaxel, carboplatin, dose dense
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.
Interventions
DRUGPaclitaxel
80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
DRUGCarboplatin
area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed | Up to 190 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Progression-free Survival (PFS) | every 3 months for up to 2 years, then every 6 months (up to 31 months) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Paclitaxel: 80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
Carboplatin: area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Hypersensitivity | 1 |
Baseline characteristics
| Characteristic | Paclitaxel + Carboplatin |
|---|---|
| Age, Customized 50-59 years | 2 Participants |
| Age, Customized 60-69 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 3 |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
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
Time frame: Up to 190 days
Population: Participants who received treatment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Paclitaxel + Carboplatin | Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed | 77.5 percent of intended cycles completed |
Secondary
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
Time frame: every 3 months for up to 2 years, then every 6 months (up to 31 months)
Population: Participants enrolled in study. Long Term Follow Up stopped after termination of study due to low accrual.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Paclitaxel + Carboplatin | Number of Participants With Progression-free Survival (PFS) | 3 months | 3 Participants |
| Paclitaxel + Carboplatin | Number of Participants With Progression-free Survival (PFS) | 6 months | 3 Participants |
| Paclitaxel + Carboplatin | Number of Participants With Progression-free Survival (PFS) | 9 months | 2 Participants |
| Paclitaxel + Carboplatin | Number of Participants With Progression-free Survival (PFS) | 12 months | 2 Participants |
| Paclitaxel + Carboplatin | Number of Participants With Progression-free Survival (PFS) | 15 months | 2 Participants |
| Paclitaxel + Carboplatin | Number of Participants With Progression-free Survival (PFS) | 18 months | 2 Participants |
| Paclitaxel + Carboplatin | Number of Participants With Progression-free Survival (PFS) | 21 months | 2 Participants |
| Paclitaxel + Carboplatin | Number of Participants With Progression-free Survival (PFS) | 24 months | 2 Participants |
| Paclitaxel + Carboplatin | Number of Participants With Progression-free Survival (PFS) | 31 months | 2 Participants |