Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

NCT00807261 | Unknown Phase 2 DMC

• 1 other identifier: DOCET_L_03981
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Primary endpoint: response rate
2. 2.Secondary endpoint: progress-free survival, overall survival, safety

Conditions

Sarcoma

Interventions

Gemcitabine and Docetaxel DRUG

Drug and schedule * Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min (D1, D8) * Docetaxel 35 mg/m2 IV (D1, D8) .. every 21 days Dose modification * Treatment should be delayed if the ANC\<1,500/ mm3, or if the platelet count \<75,000/mm3 on the first day of the next cycle. * Gemcitabine \& docetaxel are omitted on day 8, when ANC is less than 1000/mm3 or platelet count is less than 50,000/mm3; it is reduced by 25% if the ANC is between 1,000 and 1,500/mm3 or the platelet count is between 50,000 and 75,000/mm3 Study design Treatment should consist of at least 2 cycles unless rapid disease progression or unacceptable toxicities occur after one cycle of chemotherapy. Patients with response or no change will receive 2 additional cycles.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• Severance Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Samsung Medical Center: collaborator

MeSH Terms

Conditions

Sarcoma

Interventions

Gemcitabine; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Jin-hee Ahn

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 12, 2008

Record last verified: 2008-12