Lung Neoplasms, Non-Small Cell Lung CancerPhase 2NCT02275806
Cisplatin/Irinotecan With Concurrent Radiation for Inoperable NSCLC
A Phase 2 study testing Irinotecan and Cisplatin in people with Lung Neoplasms, Non-Small Cell Lung Cancer, run by Leo W. Jenkins Cancer Center at 1 site in United States.
Trial summary
This is a prospective, single institution phase II study, whose primary objective is to estimate the median and three year survival rate of non-small lung cancer patients with Stage IIIA and IIIB intra-thoracic disease which is referred to as "locally advanced" 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
- Lung Neoplasms, Non-Small Cell Lung Cancer
- What is being tested?
- Irinotecan and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 27 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological or cytological documented NSCLC, including squamous cell carcinoma, adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma adenosquamous and sarcomatoid carcinomas.
- Patients with Pancoast tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. Pancoast tumor patients will be so-noted in the registry.
- Patients must be ≥ 18 years of age.
- Patients with Zubrod (ECOG) performance status ≤ 2.
- Adequate hematologic function defined as: ANC ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin ≤ 3.0 mg/dl, and adequate renal function defined as a serum creatinine level ≤ 2.0 mg/dl.
- Patients with weight loss ≤ 20% over the past 3 months.
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- Patients with a pleural effusion that is proven cytologically negative or is too small to tap.
- Women of childbearing potential must agree to practice effective contraception throughout the study and for four weeks after completion of treatment.
- Pretreatment evaluations required for eligibility include:
- A medical history, physical examination, and assessment of Zubrod performance status within 4 weeks prior to study entry.
- CBC with differential and platelet count, and laboratory profile must be completed within 4 weeks prior to study entry.
- CT scan of the chest or whole body PET (preferred), and a CT scan or MRI (preferred) of the brain within 4 weeks prior to study entry.
- For women of childbearing potential, a serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) must be performed within a week prior to the start of protocol treatment.
- Medical Oncology and Radiation Oncology consultation and approval.
- Patients must sign a study-specific consent form prior to study entry.
Who cannot join
- Small cell carcinomas or carcinoid histology.
- History of any malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers.
- Prior systemic chemotherapy or radiotherapy that would interfere with delivery of treatment as outlined above as judged by the clinician.
- Cytologically malignant effusions.
- Radiographic evidence of metastatic disease.
- Active pulmonary infection not responsive to antimicrobial therapy.
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- History of significant or symptomatic interstitial pneumonitis.
- Significant symptomatic cardiac disease, for example, unstable angina, uncompensated congestive heart failure, or uncontrolled cardiac ventricular arrhythmias.
- Patients with > grade 2 neuropathy.
- Women who are pregnant or breast feeding, as treatment involves unforeseeable risks to the participant, embryo, fetus, or nursing infant; women with a positive pregnancy test on enrollment or prior to study drug administration.
- Women of childbearing potential who are unwilling to practice effective contraception throughout the study and for four weeks after completion of treatment.
- Patients who currently are participating in other clinical trials and/or who have participated in other clinical trials in the previous 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Leo W Jenkins Cancer Center
Greenville, North Carolina, 27834
About this study
Official title: A Phase II Study of Definitive Concurrent Radiation Therapy With Cisplatin and Irinotecan Chemotherapy in Locally Advanced In-operable Non-Small Cell Lung Cancer
This is a prospective, single institution phase II study, whose primary objective is to estimate the median and three year survival rate of non-small lung cancer patients with Stage IIIA and IIIB intra-thoracic disease which is referred to as "locally advanced" non-small cell lung cancer (NSCLC).
Read the detailed description
Patients with histological documented non-small cell lung cancer, that are considered to be inoperable, meet all the eligibility criteria, and sign informed consent will be treated with one cycle of irinotecan and cisplatin, followed by three additional cycles of chemotherapy with 60 - 70 Gy of concurrent radiation therapy.
- Being tested
- Irinotecan, Cisplatin
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrinotecanDrug
Also called Camptosar, camptothecin-11, CPT-11
CisplatinDrug
Also called Platinol, CDDP
| Study group | Role | What they receive |
|---|---|---|
| All enrolled patients | Other | Induction Chemotherapy Cycle 1 - Irinotecan 65 mg/m2 and Cisplatin 30 mg/m2 on days 1 and 8
Concurrent Chemotherapy Cycles 2-4 - Irinotecan 65 mg/m2 and Cisplatin 30 mg/m2 on days 22 and 29, days 43 and 50, and days 64 and 71 along with radiation therapy of 60-70 Gy in 2 GY fractions on days 22 -71. Receives: Drug: Irinotecan; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the median and three year survival rate of locally advanced NSCLC using the platinum doublet cisplatin and irinotecan
Measured: Three years after the last patient has completed treatement
Estimate the progression-free survival
Measured: Three years after the last patient has completed treatement.
Secondary outcomes (2)
Compare the survival of patients treated with cisplatin/irinotecan with historical controls using cisplatin/etoposide.
Measured: Three years after the last patient has completed treatment.
Measure toxicities and compliance of patients on this regimen
Measured: Thirty days after completing treatment, averaging 100 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startOct 2014
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Why it stopped: PI decided to terminate study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Neoplasms, Non-Small Cell Lung CancerStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leo W. Jenkins Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Walker, MD, FACP, Principal investigator, Brody School of Medicine at East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275806
- Sponsor's protocol ID
- LJCC 2014-01
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2014
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Definitive Concurrent Radiation Therapy With Cisplatin and Irinotecan Chemotherapy in Locally Advanced In-operable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02275806
- Acronym / sponsor ID
- LJCC 2014-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decided to terminate study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Leo W. Jenkins Cancer CenterUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 27 Oct 2014 (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.
This is a prospective, single institution phase II study, whose primary objective is to estimate the median and three year survival rate of non-small lung cancer patients with Stage IIIA and IIIB intra-thoracic disease which is referred to as "locally advanced" non-small cell lung cancer (NSCLC).
Detailed description
Patients with histological documented non-small cell lung cancer, that are considered to be inoperable, meet all the eligibility criteria, and sign informed consent will be treated with one cycle of irinotecan and cisplatin, followed by three additional cycles of chemotherapy with 60 - 70 Gy of concurrent radiation therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All enrolled patients | Other | Drug: Irinotecan, Drug: CisplatinInduction Chemotherapy Cycle 1 - Irinotecan 65 mg/m2 and Cisplatin 30 mg/m2 on days 1 and 8 Concurrent Chemotherapy Cycles 2-4 - Irinotecan 65 mg/m2 and Cisplatin 30 mg/m2 on days 22 and 29, days 43 and 50, and days 64 and 71 along with radiation therapy of 60-70 Gy in 2 GY fractions on days 22 -71. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histological or cytological documented NSCLC, including squamous cell carcinoma, adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma adenosquamous and sarcomatoid carcinomas.
- Patients with Pancoast tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field. Pancoast tumor patients will be so-noted in the registry.
- Patients must be ≥ 18 years of age.
- Patients with Zubrod (ECOG) performance status ≤ 2.
- Adequate hematologic function defined as: ANC ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin ≤ 3.0 mg/dl, and adequate renal function defined as a serum creatinine level ≤ 2.0 mg/dl.
Key exclusion criteria (12 listed)
- Small cell carcinomas or carcinoid histology.
- History of any malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers.
- Prior systemic chemotherapy or radiotherapy that would interfere with delivery of treatment as outlined above as judged by the clinician.
- Cytologically malignant effusions.
- Radiographic evidence of metastatic disease.
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, camptothecin-11, CPT-11 | Drug | All enrolled patients |
| CisplatinAlso: Platinol, CDDP | Drug | All enrolled patients |
Primary outcome
Estimate the median and three year survival rate of locally advanced NSCLC using the platinum doublet cisplatin and irinotecan
Time frame: Three years after the last patient has completed treatement
Estimate the progression-free survival
Time frame: Three years after the last patient has completed treatement.
2 secondary outcomes
Compare the survival of patients treated with cisplatin/irinotecan with historical controls using cisplatin/etoposide.
Time frame: Three years after the last patient has completed treatment.
Measure toxicities and compliance of patients on this regimen
Time frame: Thirty days after completing treatment, averaging 100 days.
Results and safety
The study was stopped early (reason given: PI decided to terminate study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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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.
Paul Walker, MD, FACP principal investigator
Brody School of Medicine at East Carolina 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 and Cisplatin in people with Lung Neoplasms, Non-Small Cell Lung Cancer, run by Leo W. Jenkins Cancer Center 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 15 inclusion and 12 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 21 Aug 2019. 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?
The study was stopped early (reason given: PI decided to terminate study). Results are not available in the source record.
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?
Estimate the median and three year survival rate of locally advanced NSCLC using the platinum doublet cisplatin and irinotecan (time frame: Three years after the last patient has completed treatement). The study lists 2 primary outcomes in all. 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 21 Aug 2019.