OsteosarcomaPhase 2NCT00523419

Chemotherapy for Patients With Osteosarcoma

A Phase 2 study testing Pemetrexed in people with Osteosarcoma, run by Eli Lilly and Company at 13 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteosarcoma
What is being tested?: Pemetrexed
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 13 sitesin 5 countries
Study dates: Sep 2007to Jun 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

13 sites in 5 countries.

Country

City, postcode or hospital

13 sites in 5 countries

France4 sites

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
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
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
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

Other trials in France

Italy3 sites

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
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
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

Other trials in Italy

Spain3 sites

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
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
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

Other trials in Spain

Germany2 sites

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
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

Other trials in Germany

United Kingdom1 site

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

Other trials in United Kingdom

About this study

Official title: Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas

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
Being tested: Pemetrexed
Medical subject headings: Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PemetrexedDrug
Also called LY231514, Alimta
500 mg/m^2, IV every 21 days until disease progression, unacceptable toxicity, participant or physician's decision.

Study groups in NCT00523419
Study group	Role	What they receive
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. Receives: Drug: Pemetrexed

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 21 months

Secondary outcomes (6)

Time to Treatment Failure
When the protocol was written, time to treatment failure (TTTF) was included as a secondary endpoint. However, it was subsequently realized that due to the design of the study, participants are treated until disease progression or discontinuation from study treatment, not for a fixed number of cycles. Therefore, it was concluded that analysis of TTTF was inappropriate with the current study design and the analysis was not conducted, since it would be essentially the same as Progression-Free Survival.
Measured: Baseline to 21 months
Correlation of Disease Outcome With Pharmacogenomic Analysis
It was planned to examine methylthioadenosine phosphorylase (MTAP) gene deletion, folate receptor alpha (FRα) and folylpoly-gamma-glutamate synthetase (FPGS) expression, and to correlate the results with the clinical data to determine the association between these factors and clinical outcome to treatment. However, due to the small number of participants with partial response (n=1), the planned statistical analyses that would correlate responders/non responders with pharmacogenomics data are no longer valid and the analyses were not conducted.
Measured: Baseline to 21 months
Number of Participants With Adverse Events (Pharmacology Toxicity)
Pharmacology toxicity was defined as serious and non-serious adverse events. Summaries of these adverse events are located in the Reported Adverse Event Section.
Measured: Baseline to 21 months
Duration of Response
The duration of a complete response (CR) or partial response (PR) was defined as the time from the first objective status assessment of CR or PR to the first date of progression or death as a result of any cause: CR was achieved if all tumor lesions disappeared; PR was achieved if there was >=30% decrease in sum of the longest diameter (LD) of target lesions (reference: baseline sum LDs) or complete disappearance of target lesions with persistence (but not worsening) of >=1 nontarget lesions and no appearance of new lesions.
Measured: Baseline to 31 months
Progression-Free Survival (PFS)
PFS was from date of study enrollment to first date of objectively determined progressive disease (PD) or death from any cause. For participants who did not die as of data cut-off date and who did not have objective PD, PFS was censored at date of last objective progression-free disease assessment. For participants who received subsequent systemic anticancer therapy (after discontinuation from study drug) before objectively determined disease progression or death, PFS was censored at date of last objective progression-free disease assessment, before post-discontinuation chemotherapy.
Measured: Baseline to 10.4 months
Overall Survival (OS) Time
OS was the duration from enrollment to death. For participants who lived, OS was censored at the last contact.
Measured: Baseline to 27.6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2007Jun 2010

First posted31 Aug 2007 (estimated)
Study startSep 2007
Primary completionJun 2009
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteosarcomaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00523419
Sponsor's protocol ID: 11814
Other IDs: H3E-EW-S115
Status last verified: Jun 2011
First submitted: 29 Aug 2007
Last updated: 28 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor
Desmoplastic Small Round Cell Tumor, Osteosarcoma
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
Neuroblastoma (NBL), Ewing Sarcoma
RecruitingPhase 1
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Advanced Solid Tumors, Ewing Sarcoma

All Osteosarcoma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Trial of Pemetrexed in Second Line Advanced/Metastatic Osteosarcomas
ClinicalTrials.gov ID: NCT00523419
Acronym / sponsor ID: 11814
Conditions: Osteosarcoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Sep 2007
Primary completion: Jun 2009 (actual)
Study completion: Jun 2010 (actual)
First posted: 31 Aug 2007 (estimated)
Results: Posted 21 Sep 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pemetrexed	Experimental	Drug: PemetrexedParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PemetrexedAlso: LY231514, Alimta500 mg/m^2, IV every 21 days until disease progression, unacceptable toxicity, participant or physician's decision.	Drug	Pemetrexed

Primary outcome

Percentage of Participants With Tumor Response
Time frame: Baseline to 21 months
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.

6 secondary outcomes

Time to Treatment Failure
Time frame: Baseline to 21 months
Correlation of Disease Outcome With Pharmacogenomic Analysis
Time frame: Baseline to 21 months
Number of Participants With Adverse Events (Pharmacology Toxicity)
Time frame: Baseline to 21 months
Duration of Response
Time frame: Baseline to 31 months
Progression-Free Survival (PFS)
Time frame: Baseline to 10.4 months
Overall Survival (OS) Time
Time frame: Baseline to 27.6 months

Results and safety

Results posted to the registry on 21 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pemetrexed	32	0

Primary outcome: Percentage of Participants With Tumor Response

Time frame: Baseline to 21 months. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pemetrexed n = 32
Response Rate	3.1 (0.1 to 16.2)
Complete Response (CR)	0 (0 to 0)
Partial Response (PR)	3.1 (0.1 to 16.2)
Stable Disease (SD)	15.6 (5.3 to 32.8)
Progressive Disease (PD)	68.8 (50.0 to 83.9)
Unknown	12.5 (3.5 to 29.0)

Population analysed: Participants who qualified for tumor response analysis are those with histological evidence of high grade locally advanced or metastatic osteosarcoma and treatment with at least 1 dose of study drug. Three participants died before the first tumor assessment and 1 participant discontinued without any tumor assessments and were considered Unknown.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pemetrexed	11 of 32 (34.4%)	26 of 32 (81.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Osteosarcoma

RecruitingPhase 2
Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor
Desmoplastic Small Round Cell Tumor, Osteosarcoma
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
Neuroblastoma (NBL), Ewing Sarcoma
RecruitingPhase 1
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Advanced Solid Tumors, Ewing Sarcoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

13 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pemetrexed in people with Osteosarcoma, run by Eli Lilly and Company at 13 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in France, Italy, Spain, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Tumor Response (time frame: Baseline to 21 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00523419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.