Chemotherapy for Patients With Osteosarcoma

NCT00523419 | Completed Phase 2 Results

• 2 other identifiers: 11814H3E-EW-S115
• Study Type: interventional
• Target: 32
• Locations: 5 countries
• Sites: 13

Brief Summary

The primary purpose of your participation in this study is to help answer the following research questions, and not to provide you treatment for your condition.

• To assess how well treatment with pemetrexed works for patients with your type of cancer
• To assess for any side effects that might be associated with pemetrexed.
• To look at the characteristics and levels of certain of your genes and proteins to learn more about osteosarcoma and how pemetrexed works in your body.

Conditions

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Tumor Response

  Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = at least a 30% decrease in sum of longest diameter of target lesions; Progressive Disease (PD) = at least a 20% increase in sum of longest diameter of target lesions; Stable Disease (SD) = small changes that do not meet above criteria. Tumor Response Rate(%) = sum of number of PR + CR observed/number of participants qualified for tumor response analysis \* 100.

  Baseline to 21 months

Secondary Outcomes (6)

• Time to Treatment Failure

  Baseline to 21 months

• Correlation of Disease Outcome With Pharmacogenomic Analysis

  Baseline to 21 months

• Number of Participants With Adverse Events (Pharmacology Toxicity)

  Baseline to 21 months

• Duration of Response

  Baseline to 31 months

• Progression-Free Survival (PFS)

  Baseline to 10.4 months

Study Arms (1)

Pemetrexed

EXPERIMENTAL

Participants received pemetrexed 500 milligrams per square meter (mg/m\^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle.

Drug: Pemetrexed

Interventions

Pemetrexed DRUG

500 mg/m\^2, IV every 21 days until disease progression, unacceptable toxicity, participant or physician's decision.

Also known as: LY231514, Alimta

Pemetrexed

Eligibility Criteria

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

You may qualify if:

• Histological diagnosis of high grade locally advanced or metastatic osteosarcoma
• Must have one prior chemotherapy regimen for advanced disease
• At least 1 unidimensional measurable lesion by computed tomography (CT) scan
• Have a good performance status
• Adequate organ function

You may not qualify if:

• Have a serious concomitant systemic disorder (for example active Human Immunodeficiency Virus infection)
• Have brain metastases not adequately treated
• Significant weight loss (that is more than 20%) over the previous 6 weeks before study entry
• Inability or unwillingness to take folic acid or vitamin B12 supplementation and corticosteroids
• Pregnant or breast-feeding

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (13)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bordeaux, 33076, France

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Lyon, 69437, France

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Marseille, 13385, France

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Villejuif, 94805, France

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Heidelberg, 69120, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Munich, 81377, Germany

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Bologna, 40136, Italy

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Milan, 20133, Italy

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Torino, 1053, Italy

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Barcelona, 08025, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Madrid, 28050, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Pamplona, 31008, Spain

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Newcastle upon Tyne, Tyneside, NE4 6BE, United Kingdom

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Osteosarcoma

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 31, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2010
• Last Updated: June 28, 2011
• Results First Posted: September 21, 2010

Record last verified: 2011-06

Locations

FR (4); ES (3); GB (1); DE (2); IT (3)