Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

Asan Medical Center

Status and phase

Unknown

Phase 2

Conditions

Sarcoma

Treatments

Drug: Gemcitabine and Docetaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00807261

DOCET_L_03981

Details and patient eligibility

About

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

Primary endpoint: response rate
Secondary endpoint: progress-free survival, overall survival, safety

Enrollment

30 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.