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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Camptothecin; Docetaxel; Irinotecan

Criteria

Inclusion Criteria:

1. Histologic diagnosis of rhabdomyosarcoma, liposarcoma, leiomyosarcoma, malignant fibrous histiocytoma, angiosarcoma, fibrosarcoma, malignant hemangiopericytoma, desmoplastic small round cell tumor, epitheloid sarcoma, clear cell sarcoma, synovial sarcoma, extraskeletal chondrosarcoma, alveolar soft part sarcoma, sarcoma not otherwise specified, malignant peripheral nerve sheath tumor, osteogenic sarcoma, Ewing's sarcoma/PPNET

2. One or more prior chemotherapy: Refractory tumors are defined as non-responsiveness to one or two regimens. In children less than 18 years, ifosfamide/carboplatin/etoposide (ICE) or VICE (vincristine + ICE) chemotherapy is recommended as a prior salvage regimen but is not mandatory.

3. Non-resectable recurrent or refractory rhabdomyosarcoma, liposarcoma, leiomyosarcoma, malignant fibrous histiocytoma, angiosarcoma, fibrosarcoma, malignant hemangiopericytoma, desmoplastic small round cell tumor, epitheloid sarcoma, clear cell sarcoma, synovial sarcoma, extraskeletal chondrosarcoma, alveolar soft part sarcoma, sarcoma not otherwise specified, malignant peripheral nerve sheath tumor, osteogenic sarcoma, Ewing's sarcoma/PPNET

4. Debulking surgery for non-resectable tumors is allowed when remained mass post-debulking is measurable enough to evaluate the response to DI.

5. Disease status must be that of measurable disease defined as:

Lesions that can be accurately measured in at least one dimension with longest diameter >20mm using conventional techniques or >10mm with spiral CT scan.

6. Age less than 50 years

7. Predicted life expectancy of more than 8 weeks

8. Performance status: ECOG 0-2 or Karnofsky ≥ 50% for patients more than 10 years of age, and Lansky ≥ 50% for children equal or less than 10 years of age.

9. Adequate major organ function defined as; Hematopoietic function: ANC> 750/μL, platelet count>75,000/μL (If peripheral blood counts are inadequate due to bone marrow infiltration, then following a bone marrow biopsy to document disease, the patient will be eligible for study, but will be inevaluable for hematological toxicity. Patients with no increase in the infiltration of the marrow on follow-up marrow exams may receive further therapy with inadequate blood counts if they have recovered from all non-hematologic toxicities.) Hepatic function: bilirubin <1.5 mg/dL, AST/ALT levels <2.5 X UNL Renal function: creatinine <1.5 X UNL for age (Table 3) or GFR ≥ 50 ml/min/1.73m2

10. Patients must not receive any other anti-cancer agents or other investigational agents during the course of this investigation or within 3 weeks prior to study entry. At least 8 weeks must have elapsed since administration of extended radiotherapy or nitrosurea. Evaluable lesions must not have any radiotherapy within 8 weeks of the start of this protocol. Previously irradiated lesions that are used to evaluate tumor response must have shown evidence of an interim increase in size. For patients who have had stem cell transplant, they must have evidence of stable engraftment without the need for significant blood product support or cytokine therapy.

11. Patients and/or their parents or legal guardians should sign a written informed consent.

Exclusion Criteria:

1. Patients who have received either prior docetaxel or irinotecan.

2. Patients who are taking anticonvulsants.

3. Patients with uncontrolled infections.

4. Women of childbearing age must not be pregnant or lactating.

5. Inadequate cardiovascular function

6. Other malignancy within the past 3 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix

7. Psychiatric disorder that would preclude compliance