Carcinoma, Non-Small-Cell LungPhase 2NCT00266812
Safety and Tolerability of Low-Dose Temozolomide During Whole Brain Radiation in Patients With Cerebral Metastases From Non-Small-Cell Lung Cancer (Study P04071)(TERMINATED)
A Phase 2 study testing Temozolomide and radiotherapy and Whole brain radiotherapy in people with Carcinoma, Non-Small-Cell Lung, run by Merck Sharp & Dohme LLC.
Trial summary
This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Temozolomide and radiotherapy and Whole brain radiotherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 8 Mar 2005to 16 Jan 2008
- 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
- Prior histologic confirmation of non-small cell lung cancer (NSCLC).
- Optional: NSCLC histologic confirmation of metastasis of NSCLC.
- Presence of unidimensionally measurable disease in the brain.
- No previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
- Age: >18 years.
- Subjects must not have systemic disease that in the opinion of the investigator is in immediate need of chemotherapy
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- Karnofsky Performance status >=70%.
- Absolute neutrophil count (ANC) >1,500/mm^3, platelets >100,000/mm^3, hemoglobin >8 g/dL.
- Serum creatinine and bilirubin <1.5 times upper normal limit of testing laboratory.
- Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) <3 times upper limit of testing laboratory.
- Palliative radiation therapy to thorax and bone or other organs (except brain) is acceptable.
- Prior neurosurgery >2 weeks from initiating treatment with temozolomide.
- Cortisone medication stable or decreasing within 2 weeks prior to initiating treatment with temozolomide.
- Patient is not pregnant or nursing and is advised and willing to use an effective method of contraception.
- Written informed consent.
Who cannot join
- Chemotherapy or biologic therapy within four weeks prior to initiating therapy with temozolomide.
- Prior radiation therapy for brain <4 weeks from initiating therapy with temozolomide.
- Surgery within two weeks prior to temozolomide administration.
- Recursive Partitioning Analysis (RPA) class III
- Patients with a single brain metastasis amenable to radiosurgery of resection
- Known Human Immunodeficiency Virus (HIV) disease.
- Acute infection requiring intravenous antibiotics.
- Any reason making compliance to the protocol improbable.
About this study
Official title: Randomized Phase II Study: Temozolomide (TMZ) Concomitant to Radiotherapy Followed by Sequential TMZ in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Central Nervous System (CNS) Metastasis Versus Radiotherapy Alone
This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2 months. Progression-free survival at 6 months, duration of overall survival, and quality of life will also be evaluated.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Temozolomide and radiotherapy, Whole brain radiotherapy
- Keywords
- temozolomide, radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temozolomide and radiotherapyDrug
Also called Temodal, TMZ, SCH 052365
Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
Whole brain radiotherapyProcedure or surgery
2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy with temozolomide and radiotherapy | Experimental | Not described Receives: Drug: Temozolomide and radiotherapy |
| Radiotherapy alone | Active comparator | Not described Receives: Procedure: Whole brain radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression-free Survival (6 Month)
The occurrence of progression will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by brain Magnetic Resonance Imanging (MRI)/Computed Tomography (CT), thorax CT, and Quality of Life (QoL) assessments. Progression-free is defined as <25% increase in tumor size on CT or MRI.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2005 (estimated)
- Study start8 Mar 2005
- Primary completion16 Jan 2008
- Study completion16 Jan 2008
Why it stopped: Patient target could not be reached within the planned timeframe.
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 Carcinoma, Non-Small-Cell LungStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AESCA Pharma GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00266812
- Sponsor's protocol ID
- P04071
- Status last verified
- May 2017
- First submitted
- 16 Dec 2005
- 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
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
- Randomized Phase II Study: Temozolomide (TMZ) Concomitant to Radiotherapy Followed by Sequential TMZ in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients With Central Nervous System (CNS) Metastasis Versus Radiotherapy Alone
- ClinicalTrials.gov ID
- NCT00266812
- Acronym / sponsor ID
- P04071
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- temozolomide, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient target could not be reached within the planned timeframe.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- AESCA Pharma GmbH
- Study start
- 8 Mar 2005 (actual)
- Primary completion
- 16 Jan 2008 (actual)
- Study completion
- 16 Jan 2008 (actual)
- First posted
- 19 Dec 2005 (estimated)
- Results
- Posted 4 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, randomized, multicenter, open-label study designed to assess the safety and tolerability of concomitant chemotherapy with low-dose temozolomide during whole brain radiation and later on at 14 days on/14 days off schedule in patients with cerebral metastases from non-small cell lung cancer (NSCLC). The response to temozolomide will be evaluated by clinical follow up and Magnetic Resonance Imaging (MRI) performed every 2 months. Progression-free survival at 6 months, duration of overall survival, and quality of life will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy with temozolomide and radiotherapy | Experimental | Drug: Temozolomide and radiotherapy |
| Radiotherapy alone | Active comparator | Procedure: Whole brain radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Prior histologic confirmation of non-small cell lung cancer (NSCLC).
- Optional: NSCLC histologic confirmation of metastasis of NSCLC.
- Presence of unidimensionally measurable disease in the brain.
- No previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix or basal and squamous carcinoma of the skin.
- Age: >18 years.
Key exclusion criteria (8 listed)
- Chemotherapy or biologic therapy within four weeks prior to initiating therapy with temozolomide.
- Prior radiation therapy for brain <4 weeks from initiating therapy with temozolomide.
- Surgery within two weeks prior to temozolomide administration.
- Recursive Partitioning Analysis (RPA) class III
- Patients with a single brain metastasis amenable to radiosurgery of resection
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 |
|---|---|---|
| Temozolomide and radiotherapyAlso: Temodal, TMZ, SCH 052365Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100 mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2). | Drug | Chemotherapy with temozolomide and radiotherapy |
| Whole brain radiotherapy2 regimens are allowed: a) 20 fractions of 2 Gray each, administered on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12. | Procedure or surgery | Radiotherapy alone |
Primary outcome
Number of Participants With Progression-free Survival (6 Month)
Time frame: 6 months
The occurrence of progression will be compared between the study groups by Kaplan-Meier curves. Responsiveness to temozolomide will be evaluated by brain Magnetic Resonance Imanging (MRI)/Computed Tomography (CT), thorax CT, and Quality of Life (QoL) assessments. Progression-free is defined as <25% increase in tumor size on CT or MRI.
Results and safety
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.
- 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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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 and radiotherapy and Whole brain radiotherapy in people with Carcinoma, Non-Small-Cell Lung, 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 15 inclusion and 8 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 4 Sep 2009). 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?
Number of Participants With Progression-free Survival (6 Month) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.