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PhaseⅡ Study of Weekly Docetaxel and Fixed-Dose Rate Gemcitabine in Patient With Previously Treated Advanced Soft Tissue and Bone Sarcoma Prospective, Open Label, Multi-Institutional


Phase 2
16 Years
N/A
Open (Enrolling by invite only)
Both
Sarcoma

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Trial Information

PhaseⅡ Study of Weekly Docetaxel and Fixed-Dose Rate Gemcitabine in Patient With Previously Treated Advanced Soft Tissue and Bone Sarcoma Prospective, Open Label, Multi-Institutional


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Jin-hee Ahn

Investigator Role:

Principal Investigator

Investigator Affiliation:

AIDS Malignancy Clinical Trials Consortium

Authority:

Korea: Food and Drug Administration

Study ID:

DOCET_L_03981

NCT ID:

NCT00807261

Start Date:

September 2008

Completion Date:

September 2010

Related Keywords:

  • Sarcoma
  • Sarcoma

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