Reduced Dexamethasone Pre-Medication Dose in Elderly Patients Receiving Weekly Docetaxel

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to explore the feasibility of an alternative dose of dexamethasone pre-medication in older breast and lung cancer patients who are receiving weekly docetaxel chemotherapy.

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

Details

• Lead Sponsor: Geriatric Oncology Consortium
• Collaborator: Sanofi
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Docetaxel

Criteria

Inclusion Criteria:

• age ≥ 65 years;

• breast or lung cancer patients to receive docetaxel therapy as per protocol;

• corticosteroid administration, other than what is prescribed in this protocol, is not permitted during study participation, except topical administration and for adverse events;

• performance status ECOG 0-2;

• peripheral neuropathy ≤ 1;

• adequate kidney and liver functions

• signed study-specific informed consent

Exclusion Criteria:

• Patients who have received an investigational drug within 4 weeks of registration;

• Prior or concurrent malignancies (other than surgically treated carcinoma in situ;

• Serious medical or psychiatric illness which would prevent informed consent;

• Life expectancy < 3 months;

• Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled.