Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT00159094
Brief Summary:
This is a phase II trial of Doxil on day 1 and vinorelbine on days 1 and 2 in women with metastatic breast cancer. Administered every 28 days. A study to assess the safety and efficacy of Doxil and vinorelbine in metastatic breast cancer.
Detailed Description:
PROTOCOL SUMMARY
Study design: Phase II trial of monthly Doxil® and vinorelbine on day 1 and 2 in women with metastatic breast cancer.
Treatment plan: Patients will continue therapy, until they have unacceptable toxicity or disease progression.
Primary endpoint: Response rate
Secondary endpoints: Time to progression, overall survival and toxicity.
Additional study objectives: Evaluation of treatment-related dyspnea, with measurement of pulse oximetry during and after drug administration, and rigorous study of patients who experience dyspnea. Palmar-plantar erythrodysesthesia (PPE) will be treated with one of 2 randomly assigned topical salves, measuring duration and severity of symptoms.
Eligibility: Women who have had prior chemotherapy in the adjuvant or metastatic setting, or both, up to 3 prior regimens. Patients having more than one prior regimen for metastatic disease must have a performance status of 0 or 1; others may have 0-2. No prior Doxil® or vinorelbine therapy. Patients are ineligible if prior anthracycline dose is greater than 400 mg/m2, or if they have primary anthracycline-refractory disease, with disease progression during treatment or with relapse/recurrence within 6 months after last dose of anthracycline. Patients must have normal neurologic, hematologic, renal and hepatic functional parameters. Asymptomatic brain metastases are permissible.
Treatment plan: Doxil® 40 mg/m2 IV infusion over 60 minutes on day 1 Vinorelbine 15 mg/m2 IV over 6 minutes on days 1 and 2 Dexamethasone 4 mg IV or 8 mg po (Doxil® pretreatment) Heparin 5000 U IV (Vinorelbine pretreatment) Pyridoxine (vitamin B6) 200 mg po qd Repeat every 28 days.
Supportive measures:
For anemia (hematocrit \< 35): Procrit® 40,000 U q wk For neutropenia (ANC \< 1,000/mm3 ): Prophylactic antibiotics (Cipro® or Septra®) For all cycles after neutropenic fever/infection or grade 3-4 stomatitis: Prophylactic Neulasta® 6 mg SQ on day 3 (This intervention may be adopted for all patients, all cycles, if 2 of the first 4 patients enrolled need it.) For PPE: randomize between 2 topical salves and document duration and severity of sx
Dose adjustments: Subsequent cycles are given on day 29 or after recovery or to grade 0-1 toxicity, with no more than 3 weeks delay. Reduce dose of both drugs by 25% if grade 3 or 4 stomatitis or palmar-plantar or grade 4 thrombocytopenia. Reduce dose of Doxil® ONLY by 50-75% if abnormal bilirubin, alkaline phosphatase and/or ALT, AST (appendix 14.3)
Study:
NCT00159094
Study Brief:
Protocol Section:
NCT00159094