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Status unknownNCT00807261Updated Dec 12, 2008

Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

A Phase 2 interventional study of Gemcitabine and Docetaxel in Sarcoma, sponsored by Asan Medical Center. Status unknown. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2008-12-12.

Sponsored by Asan Medical Center · Phase 2, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Dec 2008), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
16 Years and older
Sex
All
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Study 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
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Conditions studied

  • Sarcoma

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03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's planned enrollment of 30 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.

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Lead sponsor

Asan Medical Center is the lead sponsor of 562 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • DrugGemcitabine and Docetaxel

    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.

06

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00807261
Lead sponsor
Asan Medical Center
Collaborators
Severance Hospital, Korea University Anam Hospital, Samsung Medical Center
First posted
Dec 11, 2008
Start date
Sep 2008
Primary completion
Sep 2010 (estimated)
Completion
Sep 2010 (estimated)
Last update
Dec 12, 2008

Study contacts

Jin-hee Ahn
principal investigator · AIDS Malignancy Consortium

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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