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

NCT02756013 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CASE13815
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Malignancies

Keywords

chemotherapy dosing; Body surface area; BSA; paclitaxel; carboplatin; dose dense

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 190 days

Secondary Outcomes (1)

• Number of Participants With Progression-free Survival (PFS)

  every 3 months for up to 2 years, then every 6 months (up to 31 months)

Study Arms (1)

Paclitaxel + Carboplatin

EXPERIMENTAL

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.

Drug: Paclitaxel; Drug: Carboplatin

Interventions

Paclitaxel DRUG

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

Also known as: Taxol

Paclitaxel + Carboplatin

Carboplatin DRUG

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

Also known as: Paraplatin, Paraplatin - aqueous solution (AQ)

Paclitaxel + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Results Point of Contact

• Title: Dr. Peter Rose
• Organization: Cleveland Clinic, Case Comprehensive Cancer Center

ROSEP@ccf.org

+1 216-444-6601

Study Officials

• Peter Rose, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2016
• First Posted: April 29, 2016
• Study Start: April 20, 2016
• Primary Completion: August 16, 2018
• Study Completion: January 24, 2019
• Last Updated: June 30, 2022
• Results First Posted: August 6, 2020

Record last verified: 2022-06

Locations

US (1)