Clinical trial · Interventional
Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients w/ Body Surface Area (BSA) > 2.0
A Phase II Trial of Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients With a BSA > 2.0
NCT02756013CI-TRIAL-00059413terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of accrual - terminated
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Paclitaxel + Carboplatin
- 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.
- interventionNames
- Drug: Paclitaxel
- Drug: Carboplatin
Primary outcomes (1)
- measure
- Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed
- timeFrame
- Up to 190 days
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.