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

NCT01380275 | Unknown Phase 2 DMC

• 1 other identifier: NCCCTS-08-322
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma

Keywords

recurrent, refractory, bone, soft tissue, sarcomas

Outcome Measures

Primary Outcomes (1)

• CT or MRI image of tumor

  2 cycles after chemotherapy (6 weeks, 1cycle = 3 weeks)

Study Arms (1)

Docetaxel and Irinotecan (DI)

EXPERIMENTAL

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.

Drug: Docetaxel (Taxotere); Drug: Irinotecan

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.

Also known as: Taxotere

Docetaxel and Irinotecan (DI)

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.

Docetaxel and Irinotecan (DI)

Eligibility Criteria

• Age: 5 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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.
• 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
• Debulking surgery for non-resectable tumors is allowed when remained mass post-debulking is measurable enough to evaluate the response to DI.
• 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.
• Age less than 50 years
• Predicted life expectancy of more than 8 weeks
• 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.
• 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
• 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.
• Patients and/or their parents or legal guardians should sign a written informed consent.

You may not qualify if:

• Patients who have received either prior docetaxel or irinotecan.
• Patients who are taking anticonvulsants.
• Patients with uncontrolled infections.
• Women of childbearing age must not be pregnant or lactating.
• Inadequate cardiovascular function
• Other malignancy within the past 3 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
• Psychiatric disorder that would preclude compliance

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Related Publications (1)

• Yoon JH, Kwon MM, Park HJ, Park SY, Lim KY, Joo J, Park BK. A study of docetaxel and irinotecan in children and young adults with recurrent or refractory Ewing sarcoma family of tumors. BMC Cancer. 2014 Aug 28;14:622. doi: 10.1186/1471-2407-14-622.

  PMID: 25164234 DERIVED

MeSH Terms

Conditions

Sarcoma; Recurrence

Interventions

Docetaxel; Irinotecan

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Byung-Kiu Park, M.D.,Ph.D.

  Pediatric Oncology Branch, National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mi Mi Kwon, RN

CONTACT

82-31-920-0941; rnjsalal1004@nate.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Center for Pediatric Oncology

Study Record Dates

• First Submitted: June 21, 2011
• First Posted: June 27, 2011
• Study Start: April 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 25, 2014

Record last verified: 2014-09

Locations

KR (1)