Bone CancerPhase 2NCT01313884

Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

A Phase 2 study testing Irinotecan, Vincristine and Temozolomide in people with Bone Cancer and Ewing's Sarcoma, run by Stanford University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in… Read more about this study

Who is it for?: Ages 13 years and older
Conditions the study is for: Bone Cancer, Ewing's Sarcoma
What is being tested?: Irinotecan, Vincristine and Temozolomide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: May 2011to Jul 2014
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 13 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed diagnosis of metastatic Ewing's sarcoma.
Patients must have measurable disease defined as lesions that can be measured by medical imaging techniques such as CT or MRI. Ascites, pleural fluid, bone marrow disease, lesions seen on scan will not be considered measurable.
Patients must have metastatic disease.
Age 13 years or older
Life expectancy of at least 3 months.
ECOG performance status of <= 3.

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Normal hepatic function (Direct bilirubin <1.5mg/dl, SGOT or SGPT <3x upper limit of normal).
Left Ventricular Ejection fraction of at least 50%.
Adequate renal function: Creatinine clearance >= 50 ml/min or Serum creatinine < 1.5 x ULN for age.
Adequate bone marrow reserve (defined as an absolute peripheral granulocyte count of >=1500/mm3, platelet count of >=75,000/mm3); unless bone marrow infiltrated with metastatic Ewing's sarcoma; ANC >= 500 and Platelet >= 50,000 mm3.
Ability to understand and willing to sign a written informed consent document.
Patients of childbearing potential must agree to use an effective method of contraception.

Who cannot join

No prior chemotherapy for Ewing's sarcoma; No prior doxorubicin, temozolomide or irinotecan.
Known hypersensitivity to any of the components of the protocol drugs.
Clinically significant unrelated systemic illness (such as serious infections requiring active systemic intravenous antibiotic therapy; cardiovascular disease [congestive heart failure, recent myocardial infarction, unstable angina, inadequately controlled hypertension].
No prior history of chronic diarrhea, bowel obstruction, Crohn's disease or ulcerative colitis.
Pregnant or nursing woman are not included in the study.
HIV-positive patients will be excluded from the study due to risk of infection or other serious side effects.
Other medical, psychiatric or social condition incompatible with study treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma

Conditions: Bone Cancer, Ewing's Sarcoma
Being tested: Irinotecan, Vincristine, Temozolomide, Doxorubicin, Cytoxan
Medical subject headings: Bone Neoplasms, Sarcoma, Ewing

What participants receive

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

IrinotecanDrug
Also called Camptosar, Campto
50 mg/m2/day x 5 days
VincristineDrug
Also called Oncovin, leurocristine
2 mg/m2 to a maximum of 2 mg
TemozolomideDrug
Also called Temodar, Temodal
100 mg/m2/day x 5 days followed by 2 weeks treatment-free
DoxorubicinDrug
Also called Adriamycin, hydroxydaunorubicin
Starting dose 75 mg/m2 to a maximum of 450mg/m2
CytoxanDrug
Also called Cyclophosphamide, Endoxan, Neosar, Procytox
1200 mg/m2
PegfilgrastimDrug
Also called Neulasta
6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle

Study groups in NCT01313884
Study group	Role	What they receive
Combination Therapy	Experimental	Regimen A alternating with Regimen B every 21 days Regimen A: * Cytoxan 1200mg/m2 * Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2 * Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg * Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle Regimen B: * Irinotecan 50 mg/m2/day x 5 days * Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free Receives: Drug: Irinotecan; Drug: Vincristine; Drug: Temozolomide; Drug: Doxorubicin; Drug: Cytoxan; Drug: Pegfilgrastim

What is being measured

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

Overall Response Rate (Partial and Complete Response)
Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy.
Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters.
Measured: Up to 24 months

Secondary outcomes (1)

Progression-free Survival (PFS)
The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.
Measured: 24 months

Timeline

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

May 2011Jul 2014

First posted14 Mar 2011 (estimated)
Study startMay 2011
Primary completionJul 2014
Study completionJul 2014

Why it stopped: Study did not reach primary objective; study did not accrue enough patients.

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 Bone CancerStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01313884
Sponsor's protocol ID: IRB-20323
Other IDs: SU-03082011-7559, SARCOMA0007
Status last verified: Dec 2016
First submitted: 10 Mar 2011
Last updated: 24 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: 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

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Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma
ClinicalTrials.gov ID: NCT01313884
Acronym / sponsor ID: IRB-20323
Conditions: Bone Cancer, Ewing's Sarcoma
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study did not reach primary objective; study did not accrue enough patients.
Enrolment: 3 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: Amgen
Study start: May 2011
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 14 Mar 2011 (estimated)
Results: Posted 2 Feb 2017

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Combination Therapy	Experimental	Drug: Irinotecan, Drug: Vincristine, Drug: Temozolomide, Drug: Doxorubicin, Drug: Cytoxan, Drug: PegfilgrastimRegimen A alternating with Regimen B every 21 days Regimen A: * Cytoxan 1200mg/m2 * Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2 * Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg * Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle Regimen B: * Irinotecan 50 mg/m2/day x 5 days * Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (12 listed)

Histologically or cytologically confirmed diagnosis of metastatic Ewing's sarcoma.
Patients must have measurable disease defined as lesions that can be measured by medical imaging techniques such as CT or MRI. Ascites, pleural fluid, bone marrow disease, lesions seen on scan will not be considered measurable.
Patients must have metastatic disease.
Age 13 years or older
Life expectancy of at least 3 months.

Key exclusion criteria (7 listed)

No prior chemotherapy for Ewing's sarcoma; No prior doxorubicin, temozolomide or irinotecan.
Known hypersensitivity to any of the components of the protocol drugs.
Clinically significant unrelated systemic illness (such as serious infections requiring active systemic intravenous antibiotic therapy; cardiovascular disease [congestive heart failure, recent myocardial infarction, unstable angina, inadequately controlled hypertension].
No prior history of chronic diarrhea, bowel obstruction, Crohn's disease or ulcerative colitis.
Pregnant or nursing woman are not included in the study.

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
IrinotecanAlso: Camptosar, Campto50 mg/m2/day x 5 days	Drug	Combination Therapy
VincristineAlso: Oncovin, leurocristine2 mg/m2 to a maximum of 2 mg	Drug	Combination Therapy
TemozolomideAlso: Temodar, Temodal100 mg/m2/day x 5 days followed by 2 weeks treatment-free	Drug	Combination Therapy
DoxorubicinAlso: Adriamycin, hydroxydaunorubicinStarting dose 75 mg/m2 to a maximum of 450mg/m2	Drug	Combination Therapy
CytoxanAlso: Cyclophosphamide, Endoxan, Neosar, Procytox1200 mg/m2	Drug	Combination Therapy
PegfilgrastimAlso: Neulasta6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle	Drug	Combination Therapy

Primary outcome

Overall Response Rate (Partial and Complete Response)
Time frame: Up to 24 months
Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy. Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters.

1 secondary outcome

Progression-free Survival (PFS)
Time frame: 24 months

Results and safety

Results posted to the registry on 2 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Combination Therapy	3	2

Primary outcome: Overall Response Rate (Partial and Complete Response)

Time frame: Up to 24 months. Count of participants. Unit: Participants

Measure	Combination Therapy n = 2
Complete Response	0
Partial Response	2

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All adverse events (related and unrelated) occurring during the study (from the time the patient receives the first dose of study drug) and up to 30 days after the last dose of study medication were reported.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Combination Therapy	1 of 3 (33.3%)	3 of 3 (100%)	Not reported

Limitations and caveats (from the sponsor): Study did not reach primary objective; study didn't accrue enough patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Kristen N. Ganjoo principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan, Vincristine and Temozolomide in people with Bone Cancer and Ewing's Sarcoma, run by Stanford University at 1 site in United States.

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 12 inclusion and 7 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: stopped early, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 2 Feb 2017). 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?

Overall Response Rate (Partial and Complete Response) (time frame: Up to 24 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 NCT01313884.

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 24 Nov 2017.