Clinical Trials Logo
  1. Home
  2. Sarcoma
  3. NCT00052390

Doxorubicin and Bevacizumab in Treating Patients With Locally Recurrent or Metastatic Soft Tissue Sarcoma

Sarcoma Clinical Trial

Official title:
A Multi-Institutional, Open-Label, Phase II Study Of Doxorubicin And Bevacizumab (Anti-VEFG Monoclonal Antibody, NSC 704865) For Patients With Advanced Or Metastatic Soft-Tissue Sarcoma

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. Combining doxorubicin with bevacizumab may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining doxorubicin with bevacizumab in treating patients who have locally recurrent or metastatic soft tissue sarcoma.

Clinical Trial Description

OBJECTIVES:

- Determine the response rate (partial and complete) in patients with locally recurrent or metastatic soft tissue sarcoma treated with doxorubicin and bevacizumab.

- Determine the tolerability of this regimen in these patients.

- Determine the toxicity profile of this regimen in these patients.

- Determine whether pre-treatment plasma vascular endothelial growth factor level or microvessel density of tumor samples from these patients predicts response to this regimen.

OUTLINE: This is a multicenter study.

Patients receive doxorubicin IV over 5-10 minutes followed by bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with responding disease after reaching the maximum dose of doxorubicin may continue bevacizumab alone.

Patients are followed every 3 months for 1 year.

PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study within 13.3 months. ;

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00052390
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date October 2002
Completion date October 2005
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04986748 - Using QPOP to Predict Treatment for Sarcomas and Melanomas
Recruiting NCT04457258 - 68Ga-FAPi-46 PET/CT Scan in Imaging Patients With Sarcoma Early Phase 1
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Recruiting NCT05415098 - Study of Safety, Pharmacokinetic and Efficacy of APG-5918 in Advanced Solid Tumors or Lymphomas Phase 1
Recruiting NCT04535713 - GALLANT: Metronomic Gemcitabine, Doxorubicin, Docetaxel and Nivolumab for Advanced Sarcoma Phase 2
Completed NCT03521531 - Burden and Medical Care of Sarcoma in Germany
Completed NCT02496520 - Dendritic Cell-based Immunotherapy for Advanced Solid Tumours of Children and Young Adults Phase 1/Phase 2
Terminated NCT02054104 - Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum Phase 1/Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Active, not recruiting NCT04577014 - Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma Phase 1/Phase 2
Completed NCT04052334 - Lymphodepletion Plus Adoptive Cell Therapy With High Dose IL-2 in Adolescent and Young Adult Patients With Soft Tissue Sarcoma Phase 1
Completed NCT01593748 - A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma Phase 2
Completed NCT00199849 - NY-ESO-1 Plasmid DNA (pPJV7611) Cancer Vaccine Phase 1
Recruiting NCT04367779 - Research of Biomarkers of Response to Proton Beam Therapy in Pediatric and Adult Patients.
Completed NCT01879085 - Study of Vorinostat in Combination With Gemcitabine and Docetaxel in Advanced Sarcoma Phase 1/Phase 2
Recruiting NCT04553692 - Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers Phase 1
Completed NCT01209598 - PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma Phase 2
Completed NCT04553471 - Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers N/A
Withdrawn NCT04906876 - A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas Phase 2