Nonsquamous Nonsmall Cell Neoplasm of LungPhase 1CisPemXetSrgNCT01373463
Cisplatin and Pemetrexed With Radiation Followed by Lobectomy
A Phase 1 study testing Pemetrexed, Carboplatin and Radiation Therapy in people with Nonsquamous Nonsmall Cell Neoplasm of Lung and Nonsmall Cell Lung Cancer Stage III, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study is open to patients that have been diagnosed with non-squamous Stage III Non Small Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor. The purpose of this study is to: Test a combination of two chemotherapeutic drugs along with radiation therapy, when given prior to surgery and see what… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nonsquamous Nonsmall Cell Neoplasm of Lung, Nonsmall Cell Lung Cancer Stage III
- What is being tested?
- Pemetrexed, Carboplatin and Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jun 2012
- Phase
- Phase 1
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and cytologically confirmed non-squamous NSCLC.
- Resectable T3, and or N2 disease (T3N1, and resectable T1-3N2 multi-station non-bulky with no nodal station being more than 2 cm on preoperative workup, T4N0-1
- Resectable T3 includes patients with a satellite lesion in the same lobe as the primary.
- Male or Female, aged > or = 18 years and be able to give informed consent.
- Tumor should be technically operable with a lobectomy, bilobectomy or a sleeve resection.
- Patient should be medically operable
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- ECOG Performance Status 0 or 1.
- Adequate bone marrow, hepatic and renal function assessed within 28 days
- Signed informed consent.
- Women of childbearing potential should have negative pregnancy test prior to enrollment to study.
- Men with partners in the childbearing age group and women of childbearing potential must use effective contraception while on treatment and for 6 months thereafter.
- The ability to interrupt NSAIDS 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of Pemetrexed.
- The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.
- Patients must have a negative MRI or CT Scan of the brain.
Who cannot join
- Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds or other agents used in study.
- Pregnant or lactating women.
- Male patients with female sexual partners in the reproductive age group who refuse to use effective methods of contraception will be excluded from the trial.
- Patients with concurrent serious infections.
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- Patients with an unstable or serious concurrent medical condition are excluded.
- Presence of third space fluid which cannot be controlled by drainage.
- Weight loss > 10 percent from baseline weight.
- HIV-positive patients on combination antiretroviral therapy are ineligible
- Patients with hypercalcemia will be excluded.
- Patients who require a pneumonectomy will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Phase I Trial of Preoperative Carboplatin or Cisplatin and Pemetrexed With Thoracic Radiation Therapy Followed by Lobectomy in Resectable Stage III Patients With Non-Squamous Non Small Cell Lung Cancer (NSCLC)
This study is open to patients that have been diagnosed with non-squamous Stage III Non Small Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor.
The purpose of this study is to:
- Test a combination of two chemotherapeutic drugs along with radiation therapy, when given prior to surgery and see what effects (good or bad) it has on someone with this type of cancer. Chemotherapeutic drugs selectively destroy diseased cancer cells and tissues.
- Test the safety of different dose levels of radiation when given with each combination of chemotherapy;
- Determine what side effects are associated with combining radiation with these two chemotherapy combinations.
- Being tested
- Pemetrexed, Carboplatin, Radiation Therapy, Cisplatin, Lobectomy
- Keywords
- resectable
- 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.
PemetrexedDrug
Pemetrexed by vein every 21 days for 3 cycles
CarboplatinDrug
Carboplatin by vein Every 21 days for 3 cycles
Radiation TherapyRadiation
Radiation treatment 5 days a week for 5-6 weeks.
PemetrexedDrug
Pemetrexed by vein every 21 days for 3 cycles
CisplatinDrug
Cisplatin by vein every 21 days for 3 cycles
Radiation TherapyRadiation
Radiation treatment 5 days a week for 5-6 weeks.
LobectomyProcedure or surgery
Surgery
LobectomyProcedure or surgery
Surgery to remove a portion of the lung where the tumor is located.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 1. Patients will be given the drugs pemetrexed and carboplatin
2. Radiation
3. Participants evaluated for response
4. Lobectomy surgery Receives: Drug: Pemetrexed; Drug: Carboplatin; Radiation: Radiation Therapy; Procedure: Lobectomy |
| Arm B | Experimental | 1. Patients will be given the drugs pemetrexed and cisplatin
2. Radiation
3. Participants evaluated for response
4. Lobectomy surgery Receives: Drug: Pemetrexed; Drug: Cisplatin; Radiation: Radiation Therapy; Procedure: Lobectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Determine the safety and tolerability of concurrent chemotherapy with Cisplatin/ Pemetrexed or Carboplatin/Pemetrexed and dose escalated radiation therapy followed by lobectomy.
Secondary outcomes (1)
Response rate, overall survival and progression free survival
Evaluate the following:
- Response Rate after concurrent chemoradiation therapy.
- Overall Survival (OS).
- Progression Free Survival (PFS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Investigator left site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsquamous Nonsmall Cell Neoplasm of LungStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01373463
- Sponsor's protocol ID
- 101466
- Acronym
- CisPemXetSrg
- Status last verified
- Jul 2012
- First submitted
- 13 Jun 2011
- Last updated
- 26 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Preoperative Carboplatin or Cisplatin and Pemetrexed With Thoracic Radiation Therapy Followed by Lobectomy in Resectable Stage III Patients With Non-Squamous Non Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT01373463
- Acronym / sponsor ID
- CisPemXetSrg / 101466
- Keywords
- resectable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left site
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 15 Jun 2011 (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 study is open to patients that have been diagnosed with non-squamous Stage III Non Small Cell Lung Cancer (NSCLC) and will have surgery to remove the tumor.
The purpose of this study is to:
- Test a combination of two chemotherapeutic drugs along with radiation therapy, when given prior to surgery and see what effects (good or bad) it has on someone with this type of cancer. Chemotherapeutic drugs selectively destroy diseased cancer cells and tissues.
- Test the safety of different dose levels of radiation when given with each combination of chemotherapy;
- Determine what side effects are associated with combining radiation with these two chemotherapy combinations.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Pemetrexed, Drug: Carboplatin, Radiation: Radiation Therapy, Procedure: Lobectomy1. Patients will be given the drugs pemetrexed and carboplatin 2. Radiation 3. Participants evaluated for response 4. Lobectomy surgery |
| Arm B | Experimental | Drug: Pemetrexed, Drug: Cisplatin, Radiation: Radiation Therapy, Procedure: Lobectomy1. Patients will be given the drugs pemetrexed and cisplatin 2. Radiation 3. Participants evaluated for response 4. Lobectomy surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically and cytologically confirmed non-squamous NSCLC.
- Resectable T3, and or N2 disease (T3N1, and resectable T1-3N2 multi-station non-bulky with no nodal station being more than 2 cm on preoperative workup, T4N0-1
- Resectable T3 includes patients with a satellite lesion in the same lobe as the primary.
- Male or Female, aged > or = 18 years and be able to give informed consent.
- Tumor should be technically operable with a lobectomy, bilobectomy or a sleeve resection.
Key exclusion criteria (12 listed)
- Patients who have had chemotherapy or radiation therapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds or other agents used in study.
- Pregnant or lactating women.
- Male patients with female sexual partners in the reproductive age group who refuse to use effective methods of contraception will be excluded from the trial.
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 |
|---|---|---|
| PemetrexedPemetrexed by vein every 21 days for 3 cycles | Drug | Arm A |
| CarboplatinCarboplatin by vein Every 21 days for 3 cycles | Drug | Arm A |
| Radiation TherapyRadiation treatment 5 days a week for 5-6 weeks. | Radiation | Arm A |
| PemetrexedPemetrexed by vein every 21 days for 3 cycles | Drug | Arm B |
| CisplatinCisplatin by vein every 21 days for 3 cycles | Drug | Arm B |
| Radiation TherapyRadiation treatment 5 days a week for 5-6 weeks. | Radiation | Arm B |
| LobectomySurgery | Procedure or surgery | Arm A |
| LobectomySurgery to remove a portion of the lung where the tumor is located. | Procedure or surgery | Arm B |
Primary outcome
Safety and tolerability
Determine the safety and tolerability of concurrent chemotherapy with Cisplatin/ Pemetrexed or Carboplatin/Pemetrexed and dose escalated radiation therapy followed by lobectomy.
1 secondary outcome
Response rate, overall survival and progression free survival
Results and safety
The study was stopped early (reason given: Investigator left site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pemetrexed, Carboplatin and Radiation Therapy in people with Nonsquamous Nonsmall Cell Neoplasm of Lung and Nonsmall Cell Lung Cancer Stage III, run by Medical University of South Carolina 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 14 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 26 Jul 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 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Investigator left site). 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?
Safety and tolerability. 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 26 Jul 2012.