Gynecologic MalignanciesPhase 2NCT02756013
Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients w/ Body Surface Area (BSA) > 2.0
A Phase 2 study testing Paclitaxel and Carboplatin in people with Gynecologic Malignancies, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Malignancies
- What is being tested?
- Paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2016to 24 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: A Phase II Trial of Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients With a BSA > 2.0
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.
Read the 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.
- Conditions
- Gynecologic Malignancies
- Being tested
- Paclitaxel, Carboplatin
- Keywords
- chemotherapy dosing, Body surface area, BSA, paclitaxel, carboplatin, dose dense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
CarboplatinDrug
Also called Paraplatin, Paraplatin - aqueous solution (AQ)
area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 190 days
Secondary outcomes (1)
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
Measured: every 3 months for up to 2 years, then every 6 months (up to 31 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start20 Apr 2016
- Primary completion16 Aug 2018
- Study completion24 Jan 2019
Why it stopped: Lack of accrual - terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gynecologic MalignanciesStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rose, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756013
- Sponsor's protocol ID
- CASE13815
- Status last verified
- Jun 2022
- First submitted
- 28 Apr 2016
- Last updated
- 30 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Weight-based Dosing for Dense Weekly Paclitaxel and Carboplatin in Overweight Patients With a BSA > 2.0
- ClinicalTrials.gov ID
- NCT02756013
- Acronym / sponsor ID
- CASE13815
- Conditions
- Gynecologic Malignancies
- Keywords
- chemotherapy dosing, Body surface area, BSA, paclitaxel, carboplatin, dose dense
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of accrual - terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 20 Apr 2016 (actual)
- Primary completion
- 16 Aug 2018 (actual)
- Study completion
- 24 Jan 2019 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 6 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel + Carboplatin | Experimental | Drug: Paclitaxel, Drug: CarboplatinPaclitaxel 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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.
Key exclusion criteria (10 listed)
- 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:
- Patients who are pregnant or nursing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PaclitaxelAlso: Taxol80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles | Drug | Paclitaxel + Carboplatin |
| CarboplatinAlso: Paraplatin, Paraplatin - aqueous solution (AQ)area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles | Drug | Paclitaxel + Carboplatin |
Primary outcome
Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed
Time frame: 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
1 secondary outcome
Number of Participants With Progression-free Survival (PFS)
Time frame: every 3 months for up to 2 years, then every 6 months (up to 31 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Rose, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel and Carboplatin in people with Gynecologic Malignancies, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Dose Intensity as Measured by Mean Percent of Intended Cycles Completed (time frame: Up to 190 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.