Colorectal NeoplasmPhase 2NCT00423150

Phase 2 Study of Temozolomide in Pre-Selected Advanced Aerodigestive Tract Cancers (Study P04273AM2)(TERMINATED)

A Phase 2 study testing Temozolomide in people with Colorectal Neoplasm and Head and Neck Neoplasm, run by Merck Sharp & Dohme LLC.

Terminated

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

Official record

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Trial summary

This study is proposed to evaluate the efficacy and safety of temozolomide, an oral anti-cancer agent, in a participant population selected for a biomarker. Participants with colorectal cancer, non-small-cell lung cancer, head and neck cancer, or esophageal cancer will be included. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Neoplasm, Head and Neck Neoplasm, Carcinoma, Non-Small-Cell Lung
What is being tested?: Temozolomide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: No sites listed yet
Study dates: 26 Jan 2007to 11 Jun 2009
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

Participants must be at least 18 years of age.
Participants must have metastatic colorectal cancer (CRC), recurrent or metastatic head \& neck (H\&N) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (NSCLC).
Participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.
Participants may have up to 3 prior regimens for CRC, up to 3 prior regimens for NSCLC, up to 2 prior regimens for H\&N and esophageal cancer.
Participants must have at least one measurable lesion.
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

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Participants must have adequate hematologic, renal, and liver functions.
Participants must be able to take the study medication capsules orally, or through a feeding tube without the capsules being opened.
Participants of childbearing potential must agree to use a medically accepted method of contraception.

Who cannot join

Participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.
Participants with unstable or progressing central nervous system (CNS) metastasis. Participants with known CNS metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.
Participants who received prior temozolomide or dacarbazine treatment

About this study

Official title: A Phase 2 Study of Temozolomide (SCH 52365) in Subjects With Advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-Guanine-DNA Methyltransferase (MGMT) Promoter

Conditions: Colorectal Neoplasm, Head and Neck Neoplasm, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasm
Being tested: Temozolomide
Medical subject headings: Colorectal Neoplasms, Head and Neck Neoplasms, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms

What participants receive

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

TemozolomideDrug
Also called Temodal, TMZ, SCH 52365
Temozolomide capsules 150 mg/m^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent.

Study groups in NCT00423150
Study group	Role	What they receive
Temozolomide	Experimental	Not described Receives: Drug: Temozolomide

What is being measured

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

Tumor Responses (Complete and Partial Response)
Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST).
Complete Response (CR): Disappearance of all target lesions.
Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Measured: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first

Timeline

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

26 Jan 200711 Jun 2009

First posted18 Jan 2007 (estimated)
Study start26 Jan 2007
Primary completion11 Jun 2009
Study completion11 Jun 2009

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe 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: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00423150
Sponsor's protocol ID: P04273
Status last verified: May 2017
First submitted: 30 Nov 2006
Last updated: 8 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

Hochhauser D, Glynne-Jones R, Potter V, Gravalos C, Doyle TJ, Pathiraja K, Zhang Q, Zhang L, Sausville EA. A phase II study of temozolomide in patients with advanced aerodigestive tract and colorectal cancers and methylation of the O6-methylguanine-DNA methyltransferase promoter. Mol Cancer Ther. 2013 May;12(5):809-18. doi: 10.1158/1535-7163.MCT-12-0710. Epub 2013 Feb 26.
PubMed 23443801

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Study of Temozolomide (SCH 52365) in Subjects With Advanced Aerodigestive Tract Cancers Selected for Methylation of O6-Methyl-Guanine-DNA Methyltransferase (MGMT) Promoter
ClinicalTrials.gov ID: NCT00423150
Acronym / sponsor ID: P04273
Conditions: Colorectal Neoplasm, Head and Neck Neoplasm, Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasm
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 86 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 26 Jan 2007 (actual)
Primary completion: 11 Jun 2009 (actual)
Study completion: 11 Jun 2009 (actual)
First posted: 18 Jan 2007 (estimated)
Results: Posted 5 Jul 2010

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

Arm	Type	Receives
Temozolomide	Experimental	Drug: Temozolomide

Who may qualify

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

Key inclusion criteria (9 listed)

Participants must be at least 18 years of age.
Participants must have metastatic colorectal cancer (CRC), recurrent or metastatic head \& neck (H\&N) or esophageal cancer, or locally advanced, inoperable, or metastatic non-small cell lung cancer (NSCLC).
Participants must have a tumor sample or a blood sample tested positive for the presence of the biomarker.
Participants may have up to 3 prior regimens for CRC, up to 3 prior regimens for NSCLC, up to 2 prior regimens for H\&N and esophageal cancer.
Participants must have at least one measurable lesion.

Key exclusion criteria (3 listed)

Participants who have received treatment for a second malignancy within 1 year before screening, and are considered to be at risk of relapse within 1 year after screening.
Participants with unstable or progressing central nervous system (CNS) metastasis. Participants with known CNS metastasis may be included if a) the subject is asymptomatic, b) there is no requirement for steroids or antiseizure medications, or the required doses are stable, and c) there is no associated midline shift or (in the opinion of the investigator) significant edema.
Participants who received prior temozolomide or dacarbazine treatment

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
TemozolomideAlso: Temodal, TMZ, SCH 52365Temozolomide capsules 150 mg/m^2 daily on a 7-day on / 7-day off schedule for each 28-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent.	Drug	Temozolomide

Primary outcome

Tumor Responses (Complete and Partial Response)
Time frame: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first
Tumor response rate was based on Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Results and safety

Results posted to the registry on 5 Jul 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
Temozolomide	86	0

Primary outcome: Tumor Responses (Complete and Partial Response)

Time frame: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first. Number. Unit: Participants

Measure	Temozolomide n = 82
Number of participants with Complete Response	0
Number of participants with Partial Response	5

Population analysed: Population for the primary outcome measure is all evaluable participants per protocol definition (82 participants). Complete response is defined as disappearance of all target lesions. Partial response is defined as at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Temozolomide	37 of 86 (43%)	83 of 86 (96.5%)	Not reported

Limitations and caveats (from the sponsor): Due to low response rate for colorectal cancer in interim analyses, low enrollment in head \& neck and non-small cell lung cancer groups due to low methylation rates, and low overall response rate in esophageal cancer group, the study was terminated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23443801Hochhauser D, Glynne-Jones R, Potter V, Gravalos C, Doyle TJ, Pathiraja K, Zhang Q, Zhang L, Sausville EA. A phase II study of temozolomide in patients with advanced aerodigestive tract and colorectal cancers and methylation of the O6-methylguanine-DNA methyltransferase promoter. Mol Cancer Ther. 2013 May;12(5):809-18. doi: 10.1158/1535-7163.MCT-12-0710. Epub 2013 Feb 26.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

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Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Temozolomide in people with Colorectal Neoplasm and Head and Neck Neoplasm, run by Merck Sharp & Dohme LLC.

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 9 inclusion and 3 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 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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 5 Jul 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?

Tumor Responses (Complete and Partial Response) (time frame: From start of treatment until participant's disease progression, intolerable toxicity or death, which ever comes first). 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 NCT00423150, which also lists 1 linked publication.

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 8 Jun 2017.