Clinical trial NCT00385515: Efficacy of SNX-1012 in the Treatment of Oral Mucositis
Official title: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of SNX-1012 in Reducing the Duration and Severity of Ulcerative Oral Mucositis in Patients Receiving Cytotoxic Chemotherapy for Breast or Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomatitis
Oral Mucositis
Lead sponsor: Mucosal Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-10-09
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Oral mucositis (OM) is a common and debilitating toxicity induced by many chemotherapy (CT) regimens and by radiation to the head and neck. The purpose of this study is to determine the effectiveness of SNX-1012 in decreasing the duration of Grade 2, 3, or 4 oral mucositis (OM) according to World Health Organization (WHO) criteria.


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent
* Naive to focal radiation therapy in the head and neck regions for cancer prior to CT Cycle 1. Subjects with prior or concomitant radiation therapy to areas other than the head and neck may be enrolled.
* Histologically confirmed diagnosis of breast or lung cancer (NSCLC or SCLC)
* Chemotherapy regimen containing AC ± T or EC ± T (for breast cancer), cisplatin or carboplatin (for NSCLC or SCLC), or doxorubicin (for SCLC)
* Subjects will receive the same regimen and dose of CT in the OM Treatment CT Cycle as was administered in the immediately preceding CT Cycle.
* Subjects will have had OM of WHO Grade of greater than or equal to 2 during CT Cycle 1 or Cycle 2
* Subjects 18 years and older
* Karnofsky Performance Score \>=60
* Baseline laboratory assessments:

Hemoglobin (Hgb) level \>= 9 g/dL Absolute neutrophil count (ANC) \>= 1.5 x 10 to the 9/L Platelet count \>= 100 x 10 to the 9/L Serum bilirubin level \<= 1.5 times institutional upper limit of normal (ULN) Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) level \<= 2 times above ULN

* Females of childbearing potential must have a negative serum or urine pregnancy test result at the screening visit prior to the start of Cycle 1 and at the visit scheduled for \<= 48 hours prior to the start of the OM Treatment CT Cycle
* Subjects with reproductive capability must agree to practice adequate contraception methods (males must use condoms or be surgically sterilized; females must be surgically sterilized, post-menopausal for at least 1 year, or use an appropriate double barrier method, prescribed birth control oral contraceptive, patch, implant, or injection during the course of the study and for up to 30 days after completion of study assessments)
* Absence of other serious concurrent medical illness
* Psychologically able to participate and comply with study requirements

Exclusion Criteria:

* Prior history of oral mucositis with previous chemotherapy treatment
* Previous treatment with an anthracycline agent (other than low-dose neoadjuvant therapy)
* Active liver disease or serum AST and/or ALT level \> 2 times above ULN
* Currently receiving an investigational agent, planning to receive an investigational agent during the study period, or received an investigational agent within 30 days of the first dose of SNX-1012
* Use of an immunosuppressive regimen of systemic corticosteroids
* Unwilling/unable to receive periodic oral assessments by a study evaluator or unable to complete the daily self-reported outcome questionnaire
* Pregnant or breast-feeding women
* Bronchoalveolar carcinoma
* Metastases to the central nervous system
* Prior or planned focal radiation therapy in the head or neck regions for the treatment of cancer (prior radiation to areas other than the head and neck is permitted)
* Presence of active or history of chronic oral mucosal disease
* Presence or history of any other primary malignancy (curatively treated nonmelanoma skin cancer is allowed)
* History of chronic liver disease
* Active hepatitis A or B
* Unable to receive CT during the OM Treatment CT Cycle at the same regimen and/or dose as in the immediately preceding CT cycle.
* Known sensitivity to tetracyclines
* Known to be seropositive for HIV or HCV
* Use of an immunosuppressive regimen of systemic corticosteroids.
* Current alcohol dependence or drug abuse
* Psychological, social or familial or geographical reasons that would hinder or prevent study visits
* Compromised ability to give written informed consent and/or to comply with study procedures

Primary outcomes:
measure: Duration of Ulcerative Oral Mucositis
timeFrame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle
Secondary outcomes:
measure: Number of Participants With Ulcerative Oral Mucositis
timeFrame: At least 10 consecutive days beginning on Day 1 of a chemotherapy cycle
Other outcomes:
Locations:
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group
state: California
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: Norwich
country: United States
facility: Eastern Connecticut Hematology & Oncology Associates
state: Connecticut
city: Davie
country: United States
facility: Florida Research Cancer Institute
state: Florida
city: St Louis Park
country: United States
facility: Park Nicollet Clinic
state: Minnesota
city: Jefferson City
country: United States
facility: Capitol Comprehensive Cancer Care Clinic
state: Missouri
city: Corpus Christi
country: United States
facility: Cancer Specialists of South Texas
state: Texas
city: Abingdon
country: United States
facility: Cancer Outreach Associates
state: Virginia
city: Morgantown
country: United States
facility: Morgantown Internal Medicine Group
state: West Virginia
city: Navrangpura
country: India
facility: Vedanta Institute of Medical Sciences
state: Ahmedabad, Gujarat
city: Post Box No. 32, Idgah Hills
country: India
facility: Jawaharlal Nehru Cancer Hospital and Research Centre
state: Bhopal, Madhya Pradesh
city: 320, Mount Road, Teynampet
country: India
facility: Apollo Speciality Hospital
state: Chennai, Tamil Nadu
city: Dharamshila Marg, Vasundhara Enclave
country: India
facility: Dharamshila Cancer Hospital and Research Centre,
state: Dehli
city: Jubilee Hills
country: India
facility: Apollo Hospitals
state: Hyderabad, Andhra Pradesh
city: Punjagutta
country: India
facility: Nizams Institute of Medical Sciences
state: Hyderabad, Andhra Pradesh
city: Jawaharlal Nehru Marg
country: India
facility: Bhagwan Mahavir Cancer Hospital and Research Centre,
state: Jaipur, Rajasthan
city: Sector-5 Sikar Road
country: India
facility: S.K Sony Hospital, Vidyadhar Nagar,
state: Jaipur, Rajasthan
city: 16A Park Lane
country: India
facility: Netaji Subhash Chandra Bose Cancer Hospital & Research Institute
state: Kolkatta, West Bengal
city: 37, S.P. Mukherjee Rd.
country: India
facility: Chittaranjan National Cancer Institute
state: Kolkatta, West Bengal
city: Tagore Nagar, Civil Lines
country: India
facility: Dayanand Medical College & Hospital
state: Ludhiana, Punjab
city: 15-Dr. G. Deshmukh Marg
country: India
facility: Jaslok Hospital & Research Centre
state: Mumbai, Maharashtra
city: 32 Sassoon Road
country: India
facility: Jehangir Hospital,
state: Pune, Maharashtra
city: 40, Sassoon Road
country: India
facility: Ruby Hall Clinic,
state: Pune, Maharashtra
city: FP-402, Gokhle Nagar Road, Shivaji Nagar
country: India
facility: Seth Ramdas Shah Memorial Hospital & Research Centre
state: Pune, Maharashtra
city: Pradhan Nagar
country: India
facility: North Bengal Oncology Centre,
state: Siliguri, Dist- Darjeeling, West Bengal
city: Medical College Campus, Post Bag No. 2417
country: India
facility: Regional Cancer Centre
state: Trivandrum, Kerala
city: IDA Scuddar Road
country: India
facility: Christian Medical College & Hospital
state: Vellore, Tamil Nadu
Study officials:
References: