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Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

Primary Purpose

Sarcoma

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Gemcitabine and Docetaxel

About this trial

This is an interventional supportive care trial for Sarcoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00807261

First Posted

December 10, 2008

Last Updated

December 11, 2008

Sponsor

Asan Medical Center

Collaborators

Severance Hospital, Korea University Anam Hospital, Samsung Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00807261

Brief Title

Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Unknown status

Study Start Date

September 2008 (undefined)

Primary Completion Date

September 2010 (Anticipated)

Study Completion Date

September 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Asan Medical Center

Collaborators

Severance Hospital, Korea University Anam Hospital, Samsung Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sarcoma

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Gemcitabine and Docetaxel

Intervention Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jin-hee Ahn

Organizational Affiliation

AIDS Malignancy Consortium

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

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