Clinical Trials Logo

Clinical Trial Summary

This phase I trial is studying the side effects and best dose of cixutumumab given together with doxorubicin hydrochloride and to see how well they work in treating patients with unresectable, locally advanced, or metastatic soft tissue sarcoma. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as doxorubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody cixutumumab together with doxorubicin hydrochloride may kill more tumor cells.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To collect safety data about the combination of doxorubicin and Cixitumumab and determine if they can be combined with acceptable toxicity at full doses.

SECONDARY OBJECTIVES:

I. To assess the confirmed response rate (CR + PR as defined by RECIST) of patients with locally advanced or metastatic soft tissue sarcoma when treated with combination doxorubicin and Cixitumumab II. To assess the 3 and 6 month progression free survival rate of patients treated with doxorubicin and Cixitumumab.

III. To assess the progression free survival and overall survival of patients treated with doxorubicin and Cixitumumab.

IV. To evaluate changes in left ventricular ejection fraction assessed by MUGA scan after 2, 4 and 6 cycles of therapy compared to baseline.

OUTLINE: This is a multicenter, dose-escalation study of anti-IGF-1R recombinant monoclonal antibody cixutumumab.

Patients receive cixutumumab intravenously (IV) over 1 hour on days 1, 8, and 15 and doxorubicin hydrochloride IV continuously over 44-52 hours beginning on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may continue to receive cixutumumab in the absence of disease progression or unacceptable toxicity. ;


Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Adult Angiosarcoma
  • Adult Desmoplastic Small Round Cell Tumor
  • Adult Epithelioid Sarcoma
  • Adult Extraskeletal Myxoid Chondrosarcoma
  • Adult Extraskeletal Osteosarcoma
  • Adult Fibrosarcoma
  • Adult Leiomyosarcoma
  • Adult Liposarcoma
  • Adult Malignant Mesenchymoma
  • Adult Malignant Peripheral Nerve Sheath Tumor
  • Adult Rhabdomyosarcoma
  • Adult Synovial Sarcoma
  • Adult Undifferentiated High Grade Pleomorphic Sarcoma of Bone
  • Childhood Angiosarcoma
  • Childhood Desmoplastic Small Round Cell Tumor
  • Childhood Epithelioid Sarcoma
  • Childhood Fibrosarcoma
  • Childhood Leiomyosarcoma
  • Childhood Liposarcoma
  • Childhood Malignant Mesenchymoma
  • Childhood Malignant Peripheral Nerve Sheath Tumor
  • Childhood Pleomorphic Rhabdomyosarcoma
  • Childhood Rhabdomyosarcoma With Mixed Embryonal and Alveolar Features
  • Childhood Synovial Sarcoma
  • Chondrosarcoma
  • Dermatofibrosarcoma
  • Dermatofibrosarcoma Protuberans
  • Desmoplastic Small Round Cell Tumor
  • Fibrosarcoma
  • Hemangiopericytoma
  • Histiocytoma, Malignant Fibrous
  • Leiomyosarcoma
  • Liposarcoma
  • Liver Neoplasms
  • Malignant Adult Hemangiopericytoma
  • Malignant Childhood Hemangiopericytoma
  • Metastatic Childhood Soft Tissue Sarcoma
  • Nerve Sheath Neoplasms
  • Neurilemmoma
  • Neurofibroma
  • Osteosarcoma
  • Previously Treated Childhood Rhabdomyosarcoma
  • Recurrent Adult Soft Tissue Sarcoma
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Rhabdomyosarcoma
  • Sarcoma
  • Sarcoma, Synovial
  • Stage III Adult Soft Tissue Sarcoma
  • Stage IV Adult Soft Tissue Sarcoma
  • Untreated Childhood Rhabdomyosarcoma

NCT number NCT00720174
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 1
Start date June 2008

See also
  Status Clinical Trial Phase
Completed NCT00245102 - Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma Phase 2
Completed NCT01206140 - Selumetinib With or Without Temsirolimus in Treating Patients With Metastatic, Recurrent, or Locally Advanced Soft Tissue Sarcoma That Cannot Be Removed By Surgery Phase 2
Completed NCT01222715 - Vinorelbine Tartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma Phase 2
Completed NCT01553539 - Therapeutic Angiotensin-(1-7) in Treating Patients With Metastatic Sarcoma That Cannot Be Removed By Surgery Phase 2
Completed NCT00098579 - Doxorubicin Hydrochloride and Alvocidib in Treating Patients With Metastatic or Recurrent Sarcoma That Cannot Be Removed By Surgery Phase 1
Completed NCT00004241 - 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Advanced Epithelial Cancer, Malignant Lymphoma, or Sarcoma Phase 1
Completed NCT01462630 - Pazopanib Hydrochloride in Treating Patients With Advanced Angiosarcoma Phase 2
Completed NCT01016015 - Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma Phase 2
Terminated NCT00087191 - EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer N/A
Completed NCT00084630 - Imatinib Mesylate in Treating Patients With Locally Recurrent or Metastatic Dermatofibrosarcoma Protuberans Phase 2
Completed NCT01782313 - A Phase II Study of Tivozanib in Patients With Metastatic and Non-resectable Soft Tissue Sarcomas Phase 2
Completed NCT02357810 - Pazopanib Hydrochloride and Topotecan Hydrochloride in Treating Patients With Metastatic Soft Tissue and Bone Sarcomas Phase 2
Terminated NCT00233948 - Nelfinavir Mesylate in Treating Patients With Recurrent, Metastatic, or Unresectable Liposarcoma Phase 1/Phase 2
Active, not recruiting NCT01552434 - Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease Phase 1
Completed NCT00919269 - Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma
Completed NCT01532687 - Gemcitabine With or Without Pazopanib in Treating Patients With Refractory Soft Tissue Sarcoma Phase 2
Completed NCT01154452 - Vismodegib and Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced or Metastatic Sarcoma Phase 1/Phase 2
Completed NCT00937495 - Vorinostat and Bortezomib in Treating Patients With Advanced Soft Tissue Sarcoma Phase 2
Completed NCT00330421 - Sorafenib in Treating Patients With Soft Tissue Sarcomas (Extremity Sarcoma Closed to Entry as of 5/30/07) Phase 2
Completed NCT00087074 - CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor Phase 2