Lung CancerPhase 2NCT00006378
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer
A Phase 2 study testing carboplatin, paclitaxel and radiation therapy in people with Lung Cancer, run by Case Comprehensive Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- carboplatin, paclitaxel and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 1999to Apr 2003
- 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
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) Stage IIIA (T1-2, N2, M0 or T3, N1-2, M0) if not medically operable Stage IIIB (any T, N3, M0 or T4, any N, M0) Radiographic evidence of mediastinal lymph nodes at least 2.0 cm in the largest diameter sufficient to stage N2 or N3 disease If largest mediastinal node is less than 2.0 cm in diameter and is the basis for stage III disease, then at least one node must be histologically or cytologically confirmed positive Any of the following histologies allowed: Squamous cell carcinoma Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic carcinoma (including giant and clear cell carcinomas) Poorly differentiated NSCLC No metastatic disease Patients with tumors adjacent to a vertebral body allowed if all gross disease can be encompassed in the radiation boost field (boost volume must be limited to less than 50% of the ipsilateral lung volume) Pleural effusions that are a transudate, cytologically negative, and non-bloody are allowed if tumor can be encompassed within reasonable field of radiotherapy Pleural effusions that can be seen on chest CT but not on chest x-ray and are too small to tap are allowed No brain metastases by MRI or CT scan No prior total surgical resection
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 8 g/dL (transfusion or epoetin alfa allowed) Hepatic: Bilirubin less than 1.5 times normal Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: No history of uncontrolled serious cardiac disease No myocardial infarction within the past 6 months No congestive heart failure No unstable angina No clinically significant pericardial effusion or arrhythmia Pulmonary: FEV1 greater than 800 mL Post obstructive pneumonia allowed Other: No other active concurrent or prior malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix No other serious medical or psychiatric illness that would preclude study No active serious infection No prior significant allergic reactions to drugs containing Cremophor (e.g., cyclosporine or vitamin K) No weight loss of more than 10% within 3 months prior to diagnosis Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors (i.e., filgrastim (G-CSF) or sargramostim (GM-CSF)) No concurrent immunotherapy Concurrent epoetin alfa allowed Chemotherapy: No prior systemic chemotherapy No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal agents except for nondisease related conditions (e.g., insulin for diabetes) Concurrent steroids administered for adrenal failure or septic shock allowed Concurrent glucocorticosteroids as antiemetics allowed Radiotherapy: No prior radiotherapy to the thorax Surgery: See Disease Characteristics At least 3 weeks since formal exploratory thoracotomy and recovered At least 1 week since prior diagnostic thoracoscopy Other: No other concurrent anticancer drugs
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Morristown Memorial Hospital
Morristown, New Jersey, 07962-1956
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
About this study
Official title: Phase II Randomized Study of Taxol (PACLITAXEL), Paraplatin (Carboplatin), and Radiation Therapy for Locally Advanced Inoperable Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of combining paclitaxel and carboplatin plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be removed during surgery.
Read the detailed description
OBJECTIVES: I. Compare survival of patients with stage IIIA or IIIB unresectable non-small cell lung cancer treated with one of three different combined modality regimens of paclitaxel, carboplatin, and radiotherapy. II. Compare the safety and toxicity of these treatment regimens in these patients. III. Compare the relapse free survival rate in these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 every 3 weeks for 2 courses, followed by radiotherapy 5 times a week for 7 weeks beginning on day 42. Arm II: Patients receive paclitaxel and carboplatin as in arm I followed by radiotherapy 5 times a week, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes weekly for 7 weeks beginning on day 42. Arm III: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly and radiotherapy 5 times a week for 7 weeks beginning on day 1, followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses beginning 3 weeks after concurrent chemotherapy and radiotherapy. Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 264 patients (88 per treatment arm) will be accrued for this study within 20 months.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, paclitaxel, radiation therapy
- Keywords
- squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
paclitaxelDrug
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2004 (estimated)
- Study startDec 1999
- Primary completionApr 2003
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Case 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
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American College of Radiology
- Responsible party
- Sponsor
- Investigators
- Nathan Levitan, MD, Study chair, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006378
- Sponsor's protocol ID
- LAMP1598
- Other IDs
- CWRU-LAMP-1598, ACR-427, BMS-CWRU-LAMP-1598, CWRU-099834, NCI-G00-1867
- Status last verified
- Jan 2014
- First submitted
- 4 Oct 2000
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bonomi P, Curran W, Choy H, et al.: Randomized 3-arm phase II study of paclitaxel (T), carboplatin (C), and thoracic radiation (TRT) for patients with stage III non-small cell lung cancer (NSCLC). Report of locally advanced multimodality protocol (LAMP) - ACR 427. [Abstract] Lung Cancer 41 (Suppl 2): A-O-263, S77, 2003.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Taxol (PACLITAXEL), Paraplatin (Carboplatin), and Radiation Therapy for Locally Advanced Inoperable Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00006378
- Acronym / sponsor ID
- LAMP1598
- Conditions
- Lung Cancer
- Keywords
- squamous cell lung cancer, large cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American College of Radiology
- Study start
- Dec 1999
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 9 Jun 2004 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE: Randomized phase II trial to compare the effectiveness of three different regimens of combining paclitaxel and carboplatin plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be removed during surgery.
Detailed description
OBJECTIVES: I. Compare survival of patients with stage IIIA or IIIB unresectable non-small cell lung cancer treated with one of three different combined modality regimens of paclitaxel, carboplatin, and radiotherapy. II. Compare the safety and toxicity of these treatment regimens in these patients. III. Compare the relapse free survival rate in these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 every 3 weeks for 2 courses, followed by radiotherapy 5 times a week for 7 weeks beginning on day 42. Arm II: Patients receive paclitaxel and carboplatin as in arm I followed by radiotherapy 5 times a week, paclitaxel IV over 1 hour, and carboplatin IV over 30 minutes weekly for 7 weeks beginning on day 42. Arm III: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly and radiotherapy 5 times a week for 7 weeks beginning on day 1, followed by paclitaxel IV over 3 hours and carboplatin IV over 30 minutes every 3 weeks for 2 courses beginning 3 weeks after concurrent chemotherapy and radiotherapy. Patients are followed every 3 months for 2 years, every 4 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 264 patients (88 per treatment arm) will be accrued for this study within 20 months.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| carboplatin | Drug | – |
| paclitaxel | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
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 9 Jan 2014.
- Results publicationBonomi P, Curran W, Choy H, et al.: Randomized 3-arm phase II study of paclitaxel (T), carboplatin (C), and thoracic radiation (TRT) for patients with stage III non-small cell lung cancer (NSCLC). Report of locally advanced multimodality protocol (LAMP) - ACR 427. [Abstract] Lung Cancer 41 (Suppl 2): A-O-263, S77, 2003.
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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.
Nathan Levitan, MD study chair
Case Comprehensive Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, paclitaxel and radiation therapy in people with Lung Cancer, run by Case Comprehensive Cancer Center at 3 sites 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?
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 9 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006378, which also lists 1 linked publication.
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 9 Jan 2014.