Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

• Status: Unknown status
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the activity of weekly Docetaxel and Gemcitabine in patients with advanced soft tissue sarcoma previously treated with anthracycline and/or ifosfamide

1. Primary endpoint: response rate

2. Secondary endpoint: progress-free survival, overall survival, safety

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

Details

• Lead Sponsor: Asan Medical Center
• Collaborators: Korea University Anam Hospital; Samsung Medical Center; Severance Hospital
• Treatments: Docetaxel; Gemcitabine

Criteria

Inclusion Criteria:

• Histologically confirmed recurrent or metastatic, unresectable soft tissue sarcoma or bone sarcoma with the exception of certain histopathologic subtypes of sarcomas recognized by experts to derive no benefit from conventional chemotherapy (e.g., alveolar soft part sarcoma, clear cell sarcoma, chondrosarcoma, chordoma, desmoid tumors)

• Bone sarcoma patients must have visceral metastatic disease (e.g., metastatic to lung or liver)

• Patients who were previously treated with anthracycline- and/or ifosfamide- containing chemotherapy, as a first-line chemotherapy for metastatic disease, or adjuvant therapy Patients may have had up to 2 prior chemotherapies within 4 weeks of starting the study treatment

• unidimensional measurable lesions

• Age ≥ 16 years

• Life expectancy of more than 3 months

• ECOG performance status ≤ 2

• Adequate bone marrow function (ANC≥1,500/mm3, and platelet count ≥100,000/mm3)

• Adequate kidney function (serum creatinine ≤ 1.5 mg/dL)

• Adequate liver function (bilirubin ≤ 2 mg/dl and transaminase level ≤ 3 times the upper normal limit, or < 5 times for patients with liver metastasis, serum alkaline phosphatase < 2.5 times the upper normal limit, or < 5 times if liver metastases were present or < 10 times if bone metastases were present).

• Adequate cardiac function (Ejection fraction ≥ 50% by echoCG or MUGA scan)

• All patients are fully informed about the nature and purpose of this study and should give informed consent before the start of treatment.

Exclusion Criteria:

• Pregnant or lactating patients

• Patients with resectable lung metastasis

• Presence or history of CNS metastasis

• Prior history of other cancer within past 5 years, asides from basal cell and squamous cell carcinoma of skin, and carcinoma in situ of uterine cervix

• Any preexisting medical condition of sufficient severity to prevent full compliance with the study.