Caphosol in Oral Mucositis Due to Targeted Therapy

NCT01265810

Last updated date
Study Location
The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
Amsterdam, , 1066 CX, Netherlands
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Oral Complaints, Renal Cell Carcinoma, Hepatocellular Carcinoma, Gastrointestinal Stromal Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Oral Complaints, Renal Cell Carcinoma, Hepatocellular Carcinoma, Gastrointestinal Stromal TumorsCaphosol in Oral Mucositis Due to Targeted Therapy
NCT01265810
  1. Amsterdam,
  2. Leiden,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Caphosol in Oral Mucositis Due to Targeted Therapy
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description

OM with mucosal change, associated pain, and taste change - are clinically relevant toxicities of TKI's and mTORI's presently in use. The incidence of oral mucositis of any grade is for sunitinib 38%, sorafenib 28%, pazopanib 4%, temsirolimus 41%, and for everolimus 44%.

Optimal antitumor activity requires maintaining the highest tolerable dose in individual patients. In order to improve health related quality of life (HRQoL) and patient adherence, adverse effects should be prevented, if possible avoided and treated if necessary. Current oral formulations consist of various schedules (continuous administration or 4 weeks on, 2 weeks off) to optimize the benefit-risk profile. Adherence to anti-cancer treatment is particularly important when prescribing oral therapies as adherence to the protocol can have a significant impact on efficacy and the severity of treatment-related AEs. As sorafenib, sunitinib, pazopanib, and everolimus are taken in the outpatient setting, patient education on the correct treatment dosing, usage and the nature, recognition, and severity of AEs is essential.

Recent data suggest that TKI and mTORI associated OM is different from conventional chemotherapy related OM. Oral ulceration usually presents as aphthous-like ulcerations and has in some studies been reported as mucositis. An analysis of the appearance, course, and toxicity experiences demonstrated that the condition is distinct from conventional mucositis and more closely resembles aphthous oral mucositis. These TKI/mTORI related ulcers may represent a dose-limiting toxicity for this new class of agents, especially considering the fact that even lower grade mucositis with chronic daily dosing may be cumbersome to the patient and lead to dose reductions. Studies of treatment strategies for aphthous OM may therefore be important for the dose adherence of TKI and mTORI and for the overall acceptance of this therapy for patients.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Oral Complaints
  • Renal Cell Carcinoma
  • Hepatocellular Carcinoma
  • Gastrointestinal Stromal Tumors
Intervention  ICMJE
  • Other: supersaturated calcium-phosphate
    4 times daily, 2 minutes rinse with 30 ml solution during active rinse period (14 days)
    Other Name: Caphosol
  • Other: sodium chloride 0.9 %
    4 times daily, 2 minutes rinse with 30 ml solution during active rinse period (14 days)
Study Arms  ICMJE
  • sodium chloride -> supersaturated calcium-phosphate
    Patients in this arm start first with sodium chloride 0.9% mouth rinses and go crossover to supersaturated calcium-phosphate mouth rinses.
    Interventions:
    • Other: supersaturated calcium-phosphate
    • Other: sodium chloride 0.9 %
  • supersaturated calcium-phosphate -> sodium chloride
    Patients in this arm start first with supersaturated calcium-phosphate mouth rinses and go crossover to sodium chloride 0.9% mouth rinses.
    Interventions:
    • Other: supersaturated calcium-phosphate
    • Other: sodium chloride 0.9 %
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2017)
64
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2010)
60
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01265810
Other Study ID Numbers  ICMJE Impaqtt-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Impaqtt Foundation
Study Sponsor  ICMJE Impaqtt Foundation
Collaborators  ICMJE
  • CB Boers ORG
  • Memorial Sloan Kettering Cancer Center
  • Leiden University Medical Center
  • Pfizer
  • Novartis
  • Jazz Pharmaceuticals
Investigators  ICMJE
Principal Investigator:Christine B. Boers-Doets, MScCB Boers ORG
Principal Investigator:Mario E Lacouture, MD, PhDMemorial Sloan Kettering Cancer Center
Study Chair:Hans Gelderblom, MD, PhDLeiden University Medical Center
PRS Account Impaqtt Foundation
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP