Fentanyl Sublingual Spray in Treating Opioid-tolerant Cancer Patients With or Without Oral Mucositis
Condition: Mucositis; Pain; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Mucositis; Stomatitis
Intervention: Fentanyl sublingual spray
Intervention description: Fentanyl was supplied in single-dose glass vials assembled into a delivery device to be used as a sublingual spray.
Intervention MeSH terms: Fentanyl
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: mucositis; unspecified adult solid tumor, protocol specific; pain

Summary:

      This was an open-label, single-dose study to assess the safety, tolerability, and
      absorption/distribution kinetics of a single 100 µg dose of fentanyl sublingual spray in
      opioid-tolerant cancer subjects, with or without oral mucositis.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of cancer and meets 1 of the following criteria:

               -  Mild mucositis, defined as grade 1 (erythema of the mucosa) or 2 (patchy
                  ulcerations or pseudomembranes) on the day of study drug administration.

               -  No mucositis, defined as normal oral cavity upon examination on the day of study
                  drug administration.

          -  Opioid-tolerant, defined as patients who are taking ≥ 60 mg of oral morphine/day, ≥ 30
             mg of oxycodone/day, ≥ 8 mg of oral hydromorphone/day, or an equianalgesic dose of
             another opioid for ≥ 7 days for cancer-related pain.

          -  Persistent pain related to cancer or its treatment over the past 7 days.

          -  No brain metastases with signs or symptoms of increased intracranial pressure.

        PATIENT CHARACTERISTICS:

          -  Negative pregnancy test.

          -  Agree to be confined to study site for approximately 12 hours, to eat only the food
             served by the study unit during the study confinement period, and to consume all food
             provided at the designated meal or snack times.

          -  No history of major organ system impairment or disease that, in the investigator's or
             his/her designee's opinion, could increase the risk associated with the use of
             opioids.

          -  No uncontrolled hypertension despite antihypertensive therapy or history of
             hypertensive crisis within the past 2 years.

          -  No recent history (within the past 2 years) of transient ischemic attacks, neural
             vascular disease, stroke, or cerebral aneurysms.

          -  No intolerable side effects to opioids or fentanyl.

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics.

          -  More than 30 days since prior investigational agents.

          -  More than 14 days since prior monoamine oxidase inhibitors.

          -  No prior participation in either Insys Fentanyl Sublingual Spray Phase III study
             INSYS-INS-05-001 or INSYS-INS-06-007.

          -  No other concurrent use of any fentanyl product.

               -  Patients who have received Actiq®, Fentora®, or Duragesic® are eligible after a
                  7-day washout.

          -  No concurrent medications (prescription, over-the-counter, vitamin, or herbal
             substances) except for hormonal contraceptives and/or ≤ 3 doses of acetaminophen at ≤
             1 g each.