Trial of Docetaxel and Irinotecan (DI) for Recurrent or Refractory Bone and Soft Tissue Sarcomas.

Sponsor
National Cancer Center, Korea
Study ID
NCT01380275
Phase
PHASE2
Status
Unknown

Conditions

  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
5 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel (Taxotere) — DRUG
    This study : Docetaxel 100 mg/m2 mixed in D5W or N/S IV over 60 min: Day 1. Premedications : Dexamethasone 3 mg/m2 PO or IV 12 hours and 1 hour prior to docetaxel administration. A third dose of dexamethasone will be given 8 hours following docetaxel infusion. Patients should not be treated with docetaxel if they did not start the PO premedication the previous day. Parenteral pheniramine maleate may be given prior to docetaxel if patient has had a previous hypersensitivity to the agent. If used, pheniramine maleate (1 mg/kg IV) should be administered 30 minutes prior to infusion and every six hours thereafter, as needed.
  • Irinotecan — DRUG
    This study : Irinotecan 80 mg/m2 mixed in D5W IV over 90 min: Days 1 and 8. Premedications : Dexamethasone 3 mg/m2 PO or IV 12 hours and 1 hour prior to docetaxel administration. A third dose of dexamethasone will be given 8 hours following docetaxel infusion. Patients should not be treated with docetaxel if they did not start the PO premedication the previous day. Parenteral pheniramine maleate may be given prior to docetaxel if patient has had a previous hypersensitivity to the agent. If used, pheniramine maleate (1 mg/kg IV) should be administered 30 minutes prior to infusion and every six hours thereafter, as needed.

Study Details

The purpose of this study is to estimate the control rate (CR,PR,SD) of docetaxel and irinotecan (DI) combination chemotherapy for recurrent or refractory bone and soft tissue sarcomas.Al so, this study is to evaluate the toxicity profile of Docetaxel and Irinotecan (DI) combination chemotherapy.

Key Dates

Start date
Apr 30, 2008
Status verified
Sep 2014
Primary completion
Sep 30, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Docetaxel and Irinotecan (DI)
    Combination chemotherapy of Docetaxel and Irinotecan (DI) in recurrent or refractory bone and soft tissue sarcomas. Docetaxel and Irinotecan (DI) have different biologic targets, mode of action and mechanism of resistance. Preclinical studies have demonstrated an additive or synergistic effect of irinotecan and taxanes when used in combination in human. Docetaxel 100 mg/m2 mixed in D5W or N/S IV over 60 min: Day 1 Irinotecan 80 mg/m2 mixed in D5W IV over 90 min: Days 1 and 8 Therapy consists of 3-week cycles comprising weekly treatment for 2 weeks (docetaxel on D1 and irinotecan on D1 and D8) followed by 1-week rest, and will be continued in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

CT or MRI image of tumor [ Time Frame: 2 cycles after chemotherapy (6 weeks, 1cycle = 3 weeks) ]

Central Contacts

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