Alimta Plus Gemcitabine for Advanced Sarcoma

Status Completed

Clinical Trial Summary

In patients with unresectable soft tissue sarcoma, what is the response rate if treated with Alimta and gemcitabine?

Clinical Trial Description

Soft tissue sarcomas represent 0.7% of all malignancies diagnosed in the United States. The peak incidence occurs in children and young adults with a second peak occurring in middle age, resulting in significant morbidity and mortality in young, productive individuals. Although limb preserving surgery and radiation therapy have improved the primary treatment of these tumors, the therapy of advanced, metastatic tumors is unsatisfactory. The purpose of this phase II study is to evaluate the efficacy of treatment with Alimta and gemcitabine given on day 1 of a 14 day cycle to patients with unresectable or metastatic soft tissue sarcomas. Gemcitabine is an established salvage therapy for soft tissue sarcomas in combination with docetaxel. Alimta is a multitargeted antifolate drug which inhibits several folate dependent enzymes required for cell proliferation. Alimta has shown efficacy in several solid tumor types both as a single agent and in combination with other agents. The combination of Alimta and gemcitabine is synergistic and is likely to have efficacy against soft tissue sarcomas. The primary objective of this study is to determine the response rate among patients with unresectable soft tissue sarcoma treated with this combination. Secondary endpoints will evaluate the median survival of this patient population, as well as time to objective tumor response, time to treatment failure and overall survival. The toxicities of this regimen in this population will also be analyzed. Given the desperate need for new agents to treat these patients, a phase II trial of this combination therapy should be pursued. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00860015
Study type	Interventional
Source	Columbia University
Contact
Status	Completed
Phase	Phase 2
Start date	August 2005
Completion date	April 2012

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03985722` - Olaratumab Plus Trabectedin in Advanced Soft-tissue Sarcoma Patients Soft-tissue Sarcoma Patients	Phase 1
Withdrawn	`NCT02464332` - Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery	Phase 1
Completed	`NCT00243685` - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis	Phase 2/Phase 3
Completed	`NCT00289809` - TLC D-99 and Ifosfamide in Metastatic Soft Tissue Sarcoma Patients	Phase 1/Phase 2
Active, not recruiting	`NCT01185964` - A Study of IMC-3G3 in Soft Tissue Sarcoma	Phase 1/Phase 2
Completed	`NCT00753688` - Pazopanib Versus Placebo in Patients With Soft Tissue Sarcoma Whose Disease Has Progressed During or Following Prior Therapy	Phase 3
Completed	`NCT00187174` - Everolimus for Treating Pediatric Patients With Recurrent or Refractory Tumors	Phase 1
Completed	`NCT00093080` - Study of AP23573/MK-8669 (Ridaforolimus), A Mammalian Target of Rapamycin (mTOR) Inhibitor, in Participants With Advanced Sarcoma (MK-8669-018 AM1)(COMPLETED)	Phase 2
Completed	`NCT03798795` - Radiomics for Tumor Grading of Soft Tissue Sarcomas.
Terminated	`NCT02929394` - Trabectedin Maintenance Post 1st-line in STS	Phase 3
Recruiting	`NCT02275286` - Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients	Phase 1/Phase 2
Completed	`NCT00406601` - BAY-43-9006 in Advanced, Metastatic Soft Tissue Sarcomas	Phase 2
Completed	`NCT00297258` - Pazopanib In Patients With Relapsed Or Refractory Soft Tissue Sarcoma	Phase 2
Active, not recruiting	`NCT06114173` - Efficacy and Safety Study of Cardunilizumab in Soft Tissue Sarcoma	Early Phase 1
Completed	`NCT00061659` - Study Evaluating the Safety and Efficacy of ABT-510 in Subjects With Locally Advanced or Metastatic Soft Tissue Sarcoma	Phase 2
Recruiting	`NCT03815474` - Anlotinib Hydrochloride Combined With Epirubicin and Ifosfamide for Soft Tissue Sarcoma Patients	Phase 2
Recruiting	`NCT02812654` - Ifosfamide, Doxorubicin and Hypofractionated Radiotherapy in Neoadjuvant Sarcoma Treatment	Phase 2
Completed	`NCT00204620` - Bendamustin Hydrochloride in Patients With Soft Tissue Sarcoma (STS)	Phase 2
Completed	`NCT03058406` - A Study on Safety and Efficacy in Patients With Soft Tissue Sarcomas
Active, not recruiting	`NCT02415816` - Diffusion Weighted Magnetic Resonance in Imaging Younger Patients With Newly Diagnosed Bone or Soft Tissue Sarcomas	N/A