Hepatocellular Carcinoma Clinical Trial
— COMTTOfficial title:
Phase III Randomized Double-blind Cross-over Trial of Caphosol® Versus NaCl 0.9% in the Relief of Oral Mucositis in Renal Cell Carcinoma, Hepatocellular Carcinoma, and Gastrointestinal Stromal Tumor Patients Receiving Targeted Therapy
Verified date | November 2017 |
Source | Impaqtt Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Targeted therapies such as multi-targeted tyrosine kinase inhibitors (TKI) and mammalian
target of rapamycin inhibitors (mTORI) in renal cell carcinoma (RCC), demonstrate a high
level of efficacy with acceptable tolerability. Currently, there are five approved targeted
therapies available for RCC: sunitinib (Sutent®), sorafenib (Nexavar®), pazopanib
(Votrient®), temsirolimus (Torisel®), and everolimus (Afinitor®). Hepatocellular carcinoma
treated with sorafenib and gastro intestinal stromal tumors patients treated with sunitinib
will be included, too.
Since this agents have dermatological adverse events in common, with oral mucositis (OM),
hand-foot skin reaction (HFSR) and papulopustular eruption (PPE) as an disabling side effect,
we require evidence based management options to prevent and treat these adverse events. The
incidence of OM of any grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%, temsirolimus
41%, and everolimus 44%. Recent data suggest that TKI and mTORI associated OM is distinct
from conventional mucositis and more closely resembles aphthous OM.
Recently, supersaturated calcium-phosphate rinse (Caphosol®), a Ca2+/PO43- mouth rinse,
became available to prevent or treat OM.
The objective is to assess the relieving effect of Caphosol® oral rinse on clinical outcomes
which include oral intake, swallowing function and pain associated with incidence of grade ≥
1 oral side effects and the anticancer therapy cessation in patients treated with selected
targeted anticancer therapy.
Patients with OM > grade 0 on targeted therapy will be randomly allocated to receive either
Caphosol® or NaCl 0.9% rinse for two weeks. After the first rinse period all patients will
switch to the opposite treatment arm (NaCl 0.9% or Caphosol®) for another two weeks. Duration
of oral side effects, severity, pain, dose of analgesics and tolerability will be assessed
weekly with the Modified-VHNSS-version-2.0 oral-specific questionnaire. Patients will be
stratified by targeted anticancer agent and per tumor type (pre-defined cohorts). Objective
severity of oral side effects will be assessed using the NCI-CTCAE v4.0. Correlation of
subjective Modified-VHNSS-version-2.0 scores with the objective NCI-CTCAE grade, sex, age,
targeted therapy type, and cancer type will be conducted.
Status | Completed |
Enrollment | 64 |
Est. completion date | October 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male and female subjects - =18 years of age - Histological proof of RCC, HCC or GIST - Oral adverse events > grade 0 due to sunitinib, sorafenib, pazopanib, temsirolimus, or everolimus in mono therapy at study entry - Written informed consent - Eastern Co-operative Oncology Group (ECOG) performance status = 2 - Able to perform oral rinsing - Able to complete questionnaires by themselves or with assistance Exclusion Criteria: - Any previous systemic antineoplastic treatment within 4 weeks of initiation of current targeted anticancer therapy - Current antineoplastic combination cytotoxic chemotherapy therapy - Physiologic condition that precludes the use of an oral rinse - Hypersensitivity to Caphosol ingredients - Use of palifermin, oral cryotherapy, low level laser therapy, topical oral steroids within 3 weeks of current targeted anticancer therapy - Oral abnormalities defined as baseline oral assessment of NCI-CTCAE v4.0 grade > 0 - Current use of agents that are known to be strong inducers or inhibitors of CYP3A4 that can not be stopped |
Country | Name | City | State |
---|---|---|---|
Netherlands | The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital | Amsterdam | |
Netherlands | Leiden University Medical Centre (LUMC) | Leiden |
Lead Sponsor | Collaborator |
---|---|
Impaqtt Foundation | CB Boers ORG., Jazz Pharmaceuticals, Leiden University Medical Center, Memorial Sloan Kettering Cancer Center, Novartis, Pfizer |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess the severity of patient-reported oral adverse events as determined by the change in the Modified-VHNSS2.0 score 3 times a week, from onset of oral adverse events during the active oral rinse period with Caphosol versus NaCl 0.9% | 2 times 14 days | ||
Secondary | Determine the decrease in grade of oral adverse events as measured by the NCI-CTCAE v4.0 once a week, during a 2 week treatment with Caphosol oral rinse versus NaCl 0.9% oral rinse, 4 times daily, 2 minutes with 30 ml solution | 2 times 14 days | ||
Secondary | Assess the incidence of dose delay or dose interruption, dose reduction and discontinue treatment owing to oral burden due to targeted anticancer therapy during the active oral rinse period, once a week | 2 times 14 days | ||
Secondary | To correlate the incidence of oral mucositis with: grade = 2 hand-foot skin reaction (HFSR), and grade = 2 papulopustular eruption (PPE) with all agents as measured by the NCI-CTCAE v4.0, during the active oral rinse period, once a week | 2 times 14 days | ||
Secondary | Side Study: Explorative analysis of polymorphism in genes encoding for pharmacokinetic and pharmacodynamic variables related to the pharmacodynamics of the TKIs | once |
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