Clinical Trials Logo

Clinical Trial Summary

This phase II trial is studying how well ziv-aflibercept works in treating patients with locally advanced, unresectable or metastatic gynecologic soft tissue sarcoma. Ziv-aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To assess the objective response of recurrent or metastatic gynecologic soft-tissue sarcomas to VEGF-Trap (ziv-aflibercept).

II. To assess the incidence of disease stabilization, as measured by 6-month progression-free survival, in patients with recurrent or metastatic gynecologic soft-tissue sarcomas treated with VEGF-Trap.

SECONDARY OBJECTIVES:

I. To assess time-to-progression and overall survival in patients with recurrent or metastatic gynecologic soft-tissue sarcoma treated with VEGF-Trap.

* As of 24 October 2012, overall survival follow-up is to be discontinued for the one remaining patient on long term follow-up, who has been off protocol therapy for at least 3 years. Time to progression and median survival times have been based on the currently available data.

II. To assess the toxicity associated with VEGF-Trap in patients with recurrent or metastatic gynecologic soft-tissue sarcoma.

III. To characterize the population pharmacokinetics of VEGF-Trap and to explore for demographic and clinical covariates

OUTLINE: This is an open-label, multicenter study.

Patients are stratified according to histology (uterine leiomyosarcoma vs malignant mixed mullerian tumor/carcinosarcoma). Patients receive ziv-aflibercept over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood collection at baseline, every 8 weeks during treatment, and 60 days after completion of study treatment for population pharmacokinetic analysis using enzyme-linked immunosorbent assay (ELISA).

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00390234
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date September 2006
Completion date August 2013

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03393884 - Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2) Phase 1/Phase 2
Completed NCT04546373 - Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
Active, not recruiting NCT05456685 - IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer Phase 2
Completed NCT01442051 - Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer N/A
Completed NCT02928549 - Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
Active, not recruiting NCT03648489 - Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma) Phase 2
Not yet recruiting NCT04983550 - Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC Phase 2
Completed NCT02480374 - Study of Safety & Biological Activity of IP IMNN-001 (Also Known as GEN-1) With Neoadjuvant Chemo in Ovarian Cancer Phase 1
Completed NCT01899599 - PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer Phase 2
Completed NCT03480750 - Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer Phase 1/Phase 2
Completed NCT01610206 - A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer Phase 2
Completed NCT01219777 - Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian Phase 1
Completed NCT01031381 - Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer Phase 2
Completed NCT00959582 - Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143) Phase 1
Suspended NCT00753480 - A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Phase 1
Completed NCT00801320 - Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer N/A
Completed NCT00768144 - Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma Phase 2
Completed NCT00702299 - Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer Phase 1
Recruiting NCT02349958 - Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy Phase 2
Terminated NCT00418093 - Oxaliplatin, Gemcitabine and Bevacizumab in Women With Recurrent Mullerian Carcinoma Phase 2