Morphine After Radiofrequency Ablation of Painful Bone Metastases in Patients With Cancer

• Status: Completed
• Trial end date: 2016-03-16
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Morphine may reduce pain in patients who have undergone radiofrequency ablation to remove bone metastases.

PURPOSE: This phase II trial is studying how well morphine works after radiofrequency ablation of painful bone metastases in patients with cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Bergonié
• Treatments: Acetaminophen; Morphine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed cancer

• Primary or unknown origin

• Painful bone metastases despite radiotherapy or symptomatic relapse into previously irradiated area with no possibility of repeating radiotherapy

• Bone metastases may have been treated with bisphosphonates

• Osteolytic bone or joint (lytic and condensed) confirmed by CT scan and meeting the following criteria:

• Lesion size ≤ 5 cm

• No more than 2 painful bone metastases

• If 2 lesions are to be treated, distinct anatomical locations can be treated at the same time

• Metastatic bone lesions of the pelvis, sacrum (in absence of canal involvement), ribs, or long bones allowed

• Pain located at the tumor or in the area

• Maximum pain in the last 24 hours > 4 points (numerical scale to 11 points)

PATIENT CHARACTERISTICS:

• Life expectancy > 3 months

• Platelet count > 50,000/μL

• Prothrombin < 50%

• Activated cephalin time ≤ 1.5 times normal

• Not pregnant

• Fertile patients must use effective contraception

• No geographical, social, or psychiatric reason that would preclude follow up

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 4 weeks since prior radiotherapy

• At least 3 weeks since prior chemotherapy or bisphosphonates

• At least 1 week since beginning new painkiller therapy or anticoagulation treatment

• More than 30 days since participation in another drug study

• More than 30 days since prior surgery