NSCLCPhase 2PemSplitCispNCT01742767
Cisplatinum/Pemetrexed Versus Split-dose Cisplatinum/Pemetrexed In NSCLC
A Phase 2 study testing Cisplatinum and Pemetrexed in people with NSCLC, run by Universität Duisburg-Essen at 1 site in Germany.
Trial summary
Cisplatinum and pemetrexed (ALIMTA®) has become an effective first-line regimen for advanced and inoperable non-squamous NSCLC without somatic activating mutations of epidermal growth factor receptor (EGFR). In the standard regimen the cisplatinum dose is 75 mg/m2 on day 1 of a 21-day cycle. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC
- What is being tested?
- Cisplatinum and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Nov 2012to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible to be included in the study only if they meet all of the following criteria:
- Histologically or cytologically confirmed diagnosis of non-squamous-cell non-small cell lung cancer (NSCLC) Stage IV (American Joint Committee on Cancer Staging Criteria [AJCC], Version 7, 2009)
- No prior systemic chemotherapy for lung cancer
- At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST; version 1.1, Eisenhauer et al. 2009), longest diameter ≥10 mm with computed tomography (CT) scan [CT scan slice thickness no greater than 5 mm] , or ≥ 20 mm with chest x-ray. Positron emission tomography (PET) scans and ultrasounds should not be used.
- ECOG performance status of 0 or 1 (Oken et al. 1982)
- ≥ 18 years of age < 75 years
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- Adequate organ function,
- Prior radiation therapy allowed to <25% of the bone marrow (Cristy and Eckerman 1987). Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 4 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- Patient must understand and sign an informed consent document before the start of specific protocol procedures.
- A pretreatment FFPE tumour biopsy must be available for central biomarker analysis. If consented by the patient and clinically feasible, a fresh pretreatment biopsy is obtained and submitted for central biomarker analysis.
- Female patients with childbearing potential must use highly effective methods of contraception (combined oral contraceptives, hormon-releasing intrauterine contraceptive device, hormonal contraceptive implants, hormonal contraceptive injectables) or have sexual intercourse with a vasectomised partner only during and for 6 months after the study and their pregnancy test must be negative within 7 days prior to study enrollment.
- A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 year or unless she is surgically sterile.
- Male patients must agree to use condoms during the study and for 6 months after the study if their partner is of childbearing potential and does not use highly effective method of contraception.
- Estimated life expectancy of 12 weeks
- Patient compliance and geographic proximity that allow adequate follow up.
Who cannot join
- Patients will be excluded from the study if they meet any of the following criteria:
- Active participation in other clinical studies or treatment with any experimental drug within 30 days prior to study enrollment or during study participation.
- Patients with known somatic activating mutations of EGFR, as these patients should be offered EGFR- tyrosine kinase inhibitor (EGFR-TKI) treatment as first-line therapy. Detection of EGFR mutations and additional somatic mutations with relation to treatment will be performed centrally at the Universitätsklinikum Essen. In case immediate treatment initiation is required for medical reasons (such as superior vena cava syndrome, severely symptomatic disease) patients may be enrolled before results from EGFR testing are available. As EGFR-TKI treatment is equally effective in second-line therapy, such patients may remain on study treatment if a clinical benefit is derived.
- Peripheral neuropathy of ³CTCAE Grade 1
- Inability to comply with protocol or study procedures
- A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
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- A serious cardiac condition, such as myocardial infarction within 6 months prior to study enrollment, symptomatic coronary artery disease, cardiac arrhythmia, or other heart disease, as defined by the New York Heart Association Class III or IV (functional capacity)
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment
- Documented brain metastases unless the patient has completed successful local therapy for central nervous system metastases and has been off of corticosteroids for at least 4 weeks before enrollment. Brain imaging is required in symptomatic patients to rule out brain metastases,but is not required in asymptomatic patients
- The effect of third space fluid, such as pleural effusion and ascites, on pemetrexed is unknown. In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to pemetrexed administration.
- Significant weight loss (that is 10%) over the previous 6 weeks before study entry
- Significant hearing function impairment, especially high-frequency hearing function impairment
- Any active or uncontrolled infection
- Concurrent administration of any other antitumour therapy
- Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose <1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam)
- Inability or unwillingness to take folic acid or vitamin B12 supplementation
- Inability to take corticosteroids
- Hypersensitivity to cisplatinum or to any other platinum compound
- Hypersensitivity to pemetrexed or to any of the excipients of ALIMTA®
- Pregnant or breast-feeding patient
- Yellow fever vaccination within the 30 days previous to study entry.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University hospital essen
Essen, North Rhine-Westphalia, 45122
Diana Cortes-Incio, 02017232011, diana.cortez-incio@uk-essen.de
About this study
Official title: Randomized Phase II Trial of Three-weekly Cisplatinum and Pemetrexed Versus Split-dose d1 and d8 Cisplatinum and Pemetrexed In Advanced and Inoperable Non-squamous Non-small-cell Lung Cancer (NSCLC)
Cisplatinum and pemetrexed (ALIMTA®) has become an effective first-line regimen for advanced and inoperable non-squamous NSCLC without somatic activating mutations of epidermal growth factor receptor (EGFR). In the standard regimen the cisplatinum dose is 75 mg/m2 on day 1 of a 21-day cycle. Due to the high platinum-dose patients do need a strict hyperhydration and often have to be hospitalized for survey. Split-dose cisplatinum with two administrations on Day 1 and 8 of a 21-day-cycle has already been administered in other platin-containing chemotherapy regimens (cis/gem cis/nav cis/paclitaxel cis/docetaxel) with favourable toxicity profiles and generally with an excellent patient compliance.
Read the detailed description
There is a current need to develop a split-dose cisplatinum regimen in combination with pemetrexed with high efficacy, excellent treatment compliance, administration convenience and the possibility to open up easier outpatient administration of the chemotherapy protocol. Dosing of cisplatinum at 40 mg/m2 d 1 and day 8 seems to be very effective and useful for this strategy. The current trial will address this issue within a prospective randomized phase-II trial. Treatment will be given on day 1 and 8 in the split-dose arm. A comparator arm of the current three-weekly higher cisplatinum schedule will be added to this study. For evaluation of this strategy observation of the toxicity/efficacy ratio within this trial will be of major importance. Efficacy will be analyzed by objective response rate, symptom control and life-quality. Toxicity will be looked at with treatment toxicity, treatment compliance and adherence to protocol.
- Conditions
- NSCLC
- Being tested
- Cisplatinum, Pemetrexed
- Keywords
- NSCLC; split dose Cisplatinum; Pemetrexed
- 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.
CisplatinumDrug
PemetrexedDrug
| Study group | Role | What they receive |
|---|---|---|
| Cis (D1) + Pem (D1) | Active comparator | Cisplatinum 75 mg/m2 d 1 Pemetrexed 500 mg/m2 d 1 q d 21 Receives: Drug: Cisplatinum; Drug: Pemetrexed |
| CIS (D1+8) + Pem (D!) | Experimental | Cisplatinum 40 mg/m2 d 1 + d 8 Pemetrexed 500 mg/m2 d 1 q d 21 Receives: Drug: Cisplatinum; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2014 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- 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
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Mathias Hoiczyk, Universität Duisburg-Essen
- Investigators
- Wilfried Eberhardt, MD, Principal investigator, Universital hospital essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742767
- Sponsor's protocol ID
- 2011-001963-37
- Acronym
- PemSplitCisp
- Status last verified
- Dec 2012
- First submitted
- 3 Dec 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Three-weekly Cisplatinum and Pemetrexed Versus Split-dose d1 and d8 Cisplatinum and Pemetrexed In Advanced and Inoperable Non-squamous Non-small-cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01742767
- Acronym / sponsor ID
- PemSplitCisp / 2011-001963-37
- Conditions
- NSCLC
- Keywords
- NSCLC; split dose Cisplatinum; Pemetrexed
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Nov 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cisplatinum and pemetrexed (ALIMTA®) has become an effective first-line regimen for advanced and inoperable non-squamous NSCLC without somatic activating mutations of epidermal growth factor receptor (EGFR). In the standard regimen the cisplatinum dose is 75 mg/m2 on day 1 of a 21-day cycle. Due to the high platinum-dose patients do need a strict hyperhydration and often have to be hospitalized for survey. Split-dose cisplatinum with two administrations on Day 1 and 8 of a 21-day-cycle has already been administered in other platin-containing chemotherapy regimens (cis/gem cis/nav cis/paclitaxel cis/docetaxel) with favourable toxicity profiles and generally with an excellent patient compliance.
Detailed description
There is a current need to develop a split-dose cisplatinum regimen in combination with pemetrexed with high efficacy, excellent treatment compliance, administration convenience and the possibility to open up easier outpatient administration of the chemotherapy protocol. Dosing of cisplatinum at 40 mg/m2 d 1 and day 8 seems to be very effective and useful for this strategy. The current trial will address this issue within a prospective randomized phase-II trial. Treatment will be given on day 1 and 8 in the split-dose arm. A comparator arm of the current three-weekly higher cisplatinum schedule will be added to this study. For evaluation of this strategy observation of the toxicity/efficacy ratio within this trial will be of major importance. Efficacy will be analyzed by objective response rate, symptom control and life-quality. Toxicity will be looked at with treatment toxicity, treatment compliance and adherence to protocol.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cis (D1) + Pem (D1) | Active comparator | Drug: Cisplatinum, Drug: PemetrexedCisplatinum 75 mg/m2 d 1 Pemetrexed 500 mg/m2 d 1 q d 21 |
| CIS (D1+8) + Pem (D!) | Experimental | Drug: Cisplatinum, Drug: PemetrexedCisplatinum 40 mg/m2 d 1 + d 8 Pemetrexed 500 mg/m2 d 1 q d 21 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients are eligible to be included in the study only if they meet all of the following criteria:
- A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 year or unless she is surgically sterile.
- Male patients must agree to use condoms during the study and for 6 months after the study if their partner is of childbearing potential and does not use highly effective method of contraception.
Key exclusion criteria (21 listed)
- Patients will be excluded from the study if they meet any of the following criteria:
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 |
|---|---|---|
| Cisplatinum | Drug | CIS (D1+8) + Pem (D!), Cis (D1) + Pem (D1) |
| Pemetrexed | Drug | CIS (D1+8) + Pem (D!), Cis (D1) + Pem (D1) |
Primary outcome
Response rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
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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.
Wilfried Eberhardt, MD principal investigator
Universital hospital essen
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 Cisplatinum and Pemetrexed in people with NSCLC, run by Universität Duisburg-Essen at 1 site in Germany.
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 21 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: status not confirmed, as of the sponsor's last update on 5 Dec 2012. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wilfried Eberhardt, MD (00492017232011, wilfried.eberhardt@uk-essen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 3 years). 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 5 Dec 2012.