Combination Chemotherapy and Dexrazoxane Followed by Surgery and Radiation Therapy in Treating Patients With Advanced Soft Tissue Sarcoma or Recurrent Bone Sarcoma

NCT00544778 | Terminated Phase 2 Results

• 4 other identifiers: 00050P30CA033572CHNMC-00050CDR0000566381
• Study Type: interventional
• Target: 7
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Giving combination chemotherapy together with dexrazoxane before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with dexrazoxane followed by surgery and radiation therapy works in treating patients with advanced soft tissue sarcoma or recurrent bone sarcoma.

Conditions

Sarcoma

Keywords

recurrent adult soft tissue sarcoma; stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma; metastatic osteosarcoma; recurrent osteosarcoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; Ewing sarcoma of bone

Outcome Measures

Primary Outcomes (1)

• Response Rate

  Response rate defined as the proportion of subjects with confirmed partial or complete response as defined by the RECIST criteria.

  First disease evaluation one month after the start of treatment and every 3 months there after, up to 2 years.

Study Arms (1)

Arm 1

EXPERIMENTAL

High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.

Biological: filgrastim; Drug: dexrazoxane hydrochloride; Drug: doxorubicin hydrochloride; Drug: ifosfamide; Drug: irinotecan hydrochloride; Genetic: protein expression analysis; Other: immunoenzyme technique; Procedure: adjuvant therapy; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

Arm 1

dexrazoxane hydrochloride DRUG

Arm 1

doxorubicin hydrochloride DRUG

Arm 1

ifosfamide DRUG

Arm 1

irinotecan hydrochloride DRUG

Arm 1

protein expression analysis GENETIC

Arm 1

immunoenzyme technique OTHER

Arm 1

adjuvant therapy PROCEDURE

Arm 1

conventional surgery PROCEDURE

Arm 1

neoadjuvant therapy PROCEDURE

Arm 1

radiation therapy RADIATION

Arm 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Primary soft tissue sarcoma at high-risk\* for recurrence, meeting any of the following criteria: * Previously untreated locally advanced, nonmetastatic disease * Advanced (metastatic) disease not amenable to standard or higher priority investigational neoadjuvant therapies * Recurrent bone sarcoma (e.g., osteogenic sarcoma, Ewing sarcoma, or peripheral neuroectodermal tumor) * Must have advanced locally recurrent or metastatic disease NOTE: \*High-risk is defined as high-grade, deep to fascia, and \> 5 cm in greatest dimension * Measurable or nonmeasurable disease is not required * Pre-chemotherapy consultation with surgery and radiation oncology is required for formulation of loco-regional therapy * No gastrointestinal stromal cell sarcoma * No alveolar soft part sarcoma * No symptomatic brain metastases * No requirement for anticonvulsant or corticosteroid therapy PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Life expectancy ≥ 2 months * Absolute neutrophil count ≥ 2,000/mm\^3 * Platelet count \> 120,000/mm\^3 * Creatinine clearance \> 50 mL/min * Serum bilirubin ≤ 1.5 mg/dL * SGOT or SGPT ≤ 2.5 times upper limit of normal * Serum albumin ≥ 2.5 mg/dL * LVEF ≥ 50% by MUGA scan * Not pregnant or nursing * Fertile patients must use effective contraception * No concurrent nonmalignant illness (e.g., cardiovascular, pulmonary, or CNS disease) that is poorly controlled with currently available treatment or is of such severity that the investigators deem it unwise for the patient to enter the study PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy for recurrent (local or metastatic) soft tissue sarcoma * Prior chemotherapy for recurrent bone sarcoma allowed provided the total dose of doxorubicin hydrochloride is ≤ 300 mg/m\^2 * No prior radiotherapy to \> 25% of bone marrow * At least 3 weeks since prior radiotherapy or chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Sarcoma; Osteosarcoma; Neuroectodermal Tumors, Primitive, Peripheral

Interventions

Filgrastim; Dexrazoxane; Doxorubicin; Ifosfamide; Irinotecan; Immunoenzyme Techniques; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Razoxane; Diketopiperazines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines; Camptothecin; Alkaloids; Immunoassay; Immunologic Techniques; Investigative Techniques; Immunohistochemistry; Molecular Probe Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy

Limitations and Caveats

The study was terminated…protocol objectives not met. It was closed prematurely due to withdrawal of support by the sponsor. Subjects have been followed, but there is not enough data generated to continue following the subjects."

Results Point of Contact

• Title: Paul Frankel, Ph. D.
• Organization: City of Hope National Medical Center

pfrankel@coh.org

(626)359-8111

Study Officials

• Warren A. Chow, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2007
• First Posted: October 16, 2007
• Study Start: August 1, 2001
• Primary Completion: November 1, 2011
• Last Updated: August 28, 2014
• Results First Posted: August 28, 2014

Record last verified: 2014-08