Non Small Cell Lung CancerPhase 2NCT00280787
Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim
A Phase 2 study testing Paclitaxel, Carboplatin and CPT-11 in people with Non Small Cell Lung Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
Patients enrolled on this study will have been diagnosed with non-small cell lung cancer which cannot be removed by an operation. The standard treatment for this disease is a combination of chemotherapy and radiation therapy; however, the best way to combine these treatments is not known. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Paclitaxel, Carboplatin and CPT-11
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Oct 2010
- 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
- Subjects 18 years of age or older.
- Subjects with histologically or cytologically confirmed NSCLC that is considered generally unresectable or inoperable. No prior chemotherapy for NSCLC or thoracic radiotherapy is allowed.
- Subjects with Stage IIIA or IIIB disease (clinically or surgically staged).
- Subject with disease designated T3, N0-N1 based on mediastinal invasion or proximity to the carina.
- Subjects with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed within the radiation port.
- Subjects with pleural fluid that is a transudate and is cytologically negative.
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- Subjects with pleural effusions that are seen only on CT scan and are too small to tap.
- Subjects with measurable or evaluable disease.
- Subjects with PS of 0 or 1 by the ECOG scale (see Appendix 2).
- Subjects with laboratory values as follows:
- Absolute granulocyte count: ≥1,500/µL Platelets: ≥100,000/µL Total bilirubin: ≤1.5 x institutional upper normal limit Serum creatinine: <1.6 mg/dL or Creatinine clearance:>40 mL/min
- AST and ALT: ≤2.5 x institutional upper normal limit FEV 1 >800 cc
- Subjects must be nonpregnant and non-lactating. Subjects of childbearing potential must implement an effective method of contraception during the study. All female subjects, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.
- Subjects must have a life expectancy > 2 months.
- Subjects must be seen by both a medical oncologist and a radiation oncologist before registration.
- Subjects must be informed of the investigational nature of the study and must sign an informed consent form.
Who cannot join
- Subjects with disease designated T3, N0-N1 based on chest wall invasion, subjects with N3 supraclavicular disease, or subjects with superior sulcus tumors.
- Subjects with cytologically positive pleural effusions.
- Subjects who have received prior chemotherapy or radiochemotherapy for lung cancer or prior chest radiotherapy.
- Subjects who are < 3 weeks since formal exploratory thoracotomy.
- Subjects with a history of other cancers except in situ carcinoma of the cervix or breast, inactive nonmelanomatous skin cancer, or other cancer, unless the subject has been free of disease for > 5 years.
- Also, exceptions can be made by the PI for a subject with a malignancy for which the prognosis is substantially better than the subject's prognosis for NSCLC.
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- Subjects with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. Subjects with post-obstructive pneumonia remain eligible.
- Subjects with dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent.
- Pregnant or breast-feeding females or subjects not using adequate methods of birth control.
- Subjects receiving other investigational therapy or non-approved therapy within 30 days before Day 1 of protocol treatment.
- Subjects with known hypersensitivity to E coli-derived proteins, pegfilgrastim, or any component of the product will be excluded.
- Subjects with metastatic disease are excluded.
- Subjects taking phenytoin, rifampicin, barbiturates, carbamazepine, or St. John's Wort.
- Any evidence of clinically active ILD (subjects with chronic stable radiographic changes who are asymptomatic need not be excluded).
- Subjects with evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
- As judged by the investigator, subjects with any evidence of severe or uncontrolled systemic disease (eg, unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
- Subjects with known severe hypersensitivity to ZD1839 or any of the excipients of this product.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
About this study
Official title: LCCC 0215: Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim Support Followed by Conformal Radiotherapy and Paclitaxel/Carboplatin/ZD1839 in Locally Advanced Unresectable Stage IIIA/B Non-Small Cell Carcinoma of the Lung
Patients enrolled on this study will have been diagnosed with non-small cell lung cancer which cannot be removed by an operation. The standard treatment for this disease is a combination of chemotherapy and radiation therapy; however, the best way to combine these treatments is not known. This study will examine if the combination of chemotherapy and radiotherapy has an increased effect on slowing tumor growth with the addition of a drug called ZD1839.
In this study, chemotherapy will be given initially (induction therapy) to try to control the spread of the cancer. Then radiation and chemotherapy will be given together. Receiving chemotherapy at the same time as radiation treatments can enhance the effect of the radiation. In this study, patients will receive a drug called ZD1839. In laboratory tests on cancer cells, ZD1839 has shown an additive effect when used in combination with radiation. ZD1839 has also been shown to slow or stop growth in tumors.
The purpose of this study is to determine the side effects and effectiveness of using ZD1839 when used with radiation in this treatment regimen (induction chemotherapy followed by combination chemotherapy, ZD1839, and radiation therapy).
Read the detailed description
Lung cancer remains the leading cause of cancer-related mortality in the United States. In 2002, approximately 170,000 new cases of lung cancer will be diagnosed, and approximately 160,000 deaths will occur. Eighty percent of cases of lung cancer are of the non-small cell type, and 30 to 35% will be Stage IIIA/B and are considered potentially curable. The standard of care in the United States for those patients with unresectable Stage IIIA/B and a good performance status (PS) is a combination of systemic chemotherapy and thoracic radiation therapy (TRT). What is not clear in the management of these patients is the optimal strategy to employ in the combined-modality approach, as well as the optimal chemotherapy and radiation therapy dose and schedule.
Induction and Concurrent Chemoradiation Therapy for Stage IIIA/B NSCLC The use of combined modality has become the standard of care in unresectable Stage IIIA/B non-small cell lung cancer (NSCLC). In the curative approach to this disease, both local control and eradication of occult micrometastatic disease must be achieved. Combined-modality trials employing induction chemotherapy have suggested a reduction in the rate of metastatic disease, suggesting that effectively delivered chemotherapy can eradicate occult micrometastatic disease. All of the trials cited have shown improved survival for the combined-modality arm. Combined-modality trials employing concurrent chemoradiation have suggested improved loco-regional control resulting in improved survival. These data suggest that both induction and concurrent treatment may be important and may exert their benefit in different manners: induction therapy with effective chemotherapy reduces the rate of overt metastatic disease, while concurrent treatment improves local control by enhancing the local effect of TRT. Four trials to date have been published addressing sequential versus concurrent therapy. In these trials, concurrent treatment yielded improved survival over the sequential approach. The value of either induction or consolidation therapy in addition to concurrent chemotherapy is currently being addressed in randomized Phase III trials.
The study will evaluate the incorporation of ZD1839 with concurrent CP and TCRT to a dose of 74 Gy following 2 cycles of induction CIP. The primary objective will be to define the toxicity profile of this approach. With amendment 2, patients will no longer receive maintenance ZD1839. Given the data generated on LCCC 9603 and 2001, this "hybrid" platform of induction CIP followed by concurrent TCRT (74 Gy) and CP seems appropriate for incorporation of ZD1839 because of the general tolerance of this therapy in good PS, unresectable, Stage III NSCLC subjects. Given that esophagitis is the primary toxicity seen with this approach, stopping rules will be in place for excessive esophageal toxicity.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Paclitaxel, Carboplatin, CPT-11, Pegfilgrastim, Conformal radiotherapy
- Keywords
- unresectable, induction, radiotherapy, ZD1839
- 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.
PaclitaxelDrug
Also called Taxol
175 mg/m2 administered on Day 1, of a 21 day cycle. Subjects will receive 2 cycles
CarboplatinDrug
Also called Paraplatin
Area Under the Curve(AUC)=5 administered on Day 1 of a 21 day cycle. Subjects will receive 2 cycles.
CPT-11Drug
Also called Irinotecan
100 mg/m2 administered on Day 1 of each 21 day cycle. Subjects will receive 2 cycles.
PegfilgrastimDrug
Also called Neulasta
6 mg administered on Day 2 each each 21 day cylce. Subjects will receive 2 cycles of treatment.
Conformal radiotherapyRadiation
Radiation therapy will be administered with standard daily fractionation of 2.0 Gy per fraction, 5 days per week.The total dose of radiotherapy will be 74 Gy
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects experiencing toxicity
Toxicity of the combination of induction carboplatin/paclitaxel/irinotecan, followed by concurrent carboplatin/paclitaxel/ZD1839 and high-dose TCRT, will be assessed by CTCAE criteria
Measured: 60 days
Efficacy of 2 cycles of induction paclitaxel/carboplatin/irinotecan
To estimate the efficacy of 2 cycles (42 days) of induction paclitaxel/carboplatin/irinotecan, followed by concurrent carboplatin/paclitaxel/ZD1839 using RECIST criteria to evualate tumor response.
Measured: 42 days
Secondary outcomes (1)
Progression Free Survival
Radigraphic response measured by RECIST critera.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startNov 2003
- Primary completionJan 2006
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Amgen
- Responsible party
- Sponsor
- Investigators
- David Morris, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280787
- Sponsor's protocol ID
- LCCC 0215
- Status last verified
- Feb 2013
- First submitted
- 19 Jan 2006
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 0215: Induction Chemotherapy Using Paclitaxel, Carboplatin, CPT-11 With Pegfilgrastim Support Followed by Conformal Radiotherapy and Paclitaxel/Carboplatin/ZD1839 in Locally Advanced Unresectable Stage IIIA/B Non-Small Cell Carcinoma of the Lung
- ClinicalTrials.gov ID
- NCT00280787
- Acronym / sponsor ID
- LCCC 0215
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- unresectable, induction, radiotherapy, ZD1839
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca, Amgen
- Study start
- Nov 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 23 Jan 2006 (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.
Patients enrolled on this study will have been diagnosed with non-small cell lung cancer which cannot be removed by an operation. The standard treatment for this disease is a combination of chemotherapy and radiation therapy; however, the best way to combine these treatments is not known. This study will examine if the combination of chemotherapy and radiotherapy has an increased effect on slowing tumor growth with the addition of a drug called ZD1839.
In this study, chemotherapy will be given initially (induction therapy) to try to control the spread of the cancer. Then radiation and chemotherapy will be given together. Receiving chemotherapy at the same time as radiation treatments can enhance the effect of the radiation. In this study, patients will receive a drug called ZD1839. In laboratory tests on cancer cells, ZD1839 has shown an additive effect when used in combination with radiation. ZD1839 has also been shown to slow or stop growth in tumors.
The purpose of this study is to determine the side effects and effectiveness of using ZD1839 when used with radiation in this treatment regimen (induction chemotherapy followed by combination chemotherapy, ZD1839, and radiation therapy).
Detailed description
Lung cancer remains the leading cause of cancer-related mortality in the United States. In 2002, approximately 170,000 new cases of lung cancer will be diagnosed, and approximately 160,000 deaths will occur. Eighty percent of cases of lung cancer are of the non-small cell type, and 30 to 35% will be Stage IIIA/B and are considered potentially curable. The standard of care in the United States for those patients with unresectable Stage IIIA/B and a good performance status (PS) is a combination of systemic chemotherapy and thoracic radiation therapy (TRT). What is not clear in the management of these patients is the optimal strategy to employ in the combined-modality approach, as well as the optimal chemotherapy and radiation therapy dose and schedule.
Induction and Concurrent Chemoradiation Therapy for Stage IIIA/B NSCLC The use of combined modality has become the standard of care in unresectable Stage IIIA/B non-small cell lung cancer (NSCLC). In the curative approach to this disease, both local control and eradication of occult micrometastatic disease must be achieved. Combined-modality trials employing induction chemotherapy have suggested a reduction in the rate of metastatic disease, suggesting that effectively delivered chemotherapy can eradicate occult micrometastatic disease. All of the trials cited have shown improved survival for the combined-modality arm. Combined-modality trials employing concurrent chemoradiation have suggested improved loco-regional control resulting in improved survival. These data suggest that both induction and concurrent treatment may be important and may exert their benefit in different manners: induction therapy with effective chemotherapy reduces the rate of overt metastatic disease, while concurrent treatment improves local control by enhancing the local effect of TRT. Four trials to date have been published addressing sequential versus concurrent therapy. In these trials, concurrent treatment yielded improved survival over the sequential approach. The value of either induction or consolidation therapy in addition to concurrent chemotherapy is currently being addressed in randomized Phase III trials.
The study will evaluate the incorporation of ZD1839 with concurrent CP and TCRT to a dose of 74 Gy following 2 cycles of induction CIP. The primary objective will be to define the toxicity profile of this approach. With amendment 2, patients will no longer receive maintenance ZD1839. Given the data generated on LCCC 9603 and 2001, this "hybrid" platform of induction CIP followed by concurrent TCRT (74 Gy) and CP seems appropriate for incorporation of ZD1839 because of the general tolerance of this therapy in good PS, unresectable, Stage III NSCLC subjects. Given that esophagitis is the primary toxicity seen with this approach, stopping rules will be in place for excessive esophageal toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Subjects 18 years of age or older.
- Subjects with histologically or cytologically confirmed NSCLC that is considered generally unresectable or inoperable. No prior chemotherapy for NSCLC or thoracic radiotherapy is allowed.
- Subjects with Stage IIIA or IIIB disease (clinically or surgically staged).
- Subject with disease designated T3, N0-N1 based on mediastinal invasion or proximity to the carina.
- Subjects with contralateral mediastinal disease (N3) are eligible if all gross disease can be encompassed within the radiation port.
Key exclusion criteria (17 listed)
- Subjects with disease designated T3, N0-N1 based on chest wall invasion, subjects with N3 supraclavicular disease, or subjects with superior sulcus tumors.
- Subjects with cytologically positive pleural effusions.
- Subjects who have received prior chemotherapy or radiochemotherapy for lung cancer or prior chest radiotherapy.
- Subjects who are < 3 weeks since formal exploratory thoracotomy.
- Subjects with a history of other cancers except in situ carcinoma of the cervix or breast, inactive nonmelanomatous skin cancer, or other cancer, unless the subject has been free of disease for > 5 years.
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 |
|---|---|---|
| PaclitaxelAlso: Taxol175 mg/m2 administered on Day 1, of a 21 day cycle. Subjects will receive 2 cycles | Drug | – |
| CarboplatinAlso: ParaplatinArea Under the Curve(AUC)=5 administered on Day 1 of a 21 day cycle. Subjects will receive 2 cycles. | Drug | – |
| CPT-11Also: Irinotecan100 mg/m2 administered on Day 1 of each 21 day cycle. Subjects will receive 2 cycles. | Drug | – |
| PegfilgrastimAlso: Neulasta6 mg administered on Day 2 each each 21 day cylce. Subjects will receive 2 cycles of treatment. | Drug | – |
| Conformal radiotherapyRadiation therapy will be administered with standard daily fractionation of 2.0 Gy per fraction, 5 days per week.The total dose of radiotherapy will be 74 Gy | Radiation | – |
Primary outcome
Number of subjects experiencing toxicity
Time frame: 60 days
Toxicity of the combination of induction carboplatin/paclitaxel/irinotecan, followed by concurrent carboplatin/paclitaxel/ZD1839 and high-dose TCRT, will be assessed by CTCAE criteria
Efficacy of 2 cycles of induction paclitaxel/carboplatin/irinotecan
Time frame: 42 days
To estimate the efficacy of 2 cycles (42 days) of induction paclitaxel/carboplatin/irinotecan, followed by concurrent carboplatin/paclitaxel/ZD1839 using RECIST criteria to evualate tumor response.
1 secondary outcome
Progression Free Survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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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.
David Morris, MD principal investigator
University of North Carolina, Chapel Hill
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 Paclitaxel, Carboplatin and CPT-11 in people with Non Small Cell Lung Cancer, run by UNC Lineberger Comprehensive 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 16 inclusion and 17 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: finished, as of the sponsor's last update on 5 Feb 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 subjects experiencing toxicity (time frame: 60 days). 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 5 Feb 2013.