NCT01380275

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

Docetaxel, Irinotecan, Recurrent, Refractory, Bone and Soft Tissue Sarcomas

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: National Cancer Center, Korea · Other Government
• Sex: All
• Age: 5 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Treatment setting:Hospitalization is preferred, but treatment on the outpatient base is allowed. Regimen and premedication 1. Regimen 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 2. 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. Treatment interval and overall treatment period : 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. Maximal number of cycles is twelve, however, additional cycles may be employed only when at least PR is maintained and patients want to take more. Treatment modifications : Toxicity is evaluated according to common terminology criteria for adverse events v3.0 (CTCAE) of the National Cancer Institute. Next cycle is to be delayed until ANC count on the starting day of scheduled treatment is at least 750/μL and platelet count is at least 75,000/μL, when full doses of irinotecan and docetaxel will be given. Next cycle is also delayed if diarrhea of grade 2 or higher (including moderate cramping) occurs on the day when the dose is due. Irinotecan treatment of D8 will be delayed to D10 if grade 2 or higher non-hematological toxicity occurred on the day when the dose is due. Irinotecan scheduled at D8 will be omitted if diarrhea of grade 2 or higher occurred on the D10. Doses of docetaxel and irinotecan in the subsequent cycles are reduced by 20% for febrile grade 4 neutropenia (ANC\<500/μL). Subsequent dose will be reduced by 20% for the recurrent toxicity. G-CSF is allowed if clinically indicated according to the ASCO guideline (22). Dose of docetaxel in the subsequent cycles are reduced by 20% for grade 2 neurologic toxicity/recurrent fluid retention, or any grade 3 non-hematologic toxicities, including hepatotoxicity, peripheral neuropathy, stomatitis, skin eruption, myalgia, cardiac events, or hypersensitivity. Subsequent dose will be reduced by 20% for the recurrent toxicity. In patients with grade 2 or higher fluid retention syndrome, prophylactic dexamethasone will be given by 6 mg/m2 bid for 3 days. Dose re-escalation after dose reduction is not permitted. Docetaxel and Irinotecan (DI) treatment will be discontinued in patients with grade 4 non-hematological toxicities at the discretion of investigators. Dose modification schedule : Docetaxel and Irinotecan (DI) dose adjustment within a cycle will be made following the guidelines shown in Table 1 and 2 based on weekly WBC count and criteria for adverse events v3.0 (CTCAE).

Conditions

• Sarcoma

Interventions

Type	Name	Description
DRUG	Docetaxel (Taxotere)	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.
DRUG	Irinotecan	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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2014-09-01
• Completion: 2014-12-01
• First posted: 2011-06-27
• Last updated: 2014-09-25

Locations

1 site across 1 country: South Korea