Lung Cancer Treatment Trials
Phase III Randomized Study of Adjuvant Chemotherapy Versus Observation in Patients With Stage I Non-Small Cell Lung Cancer (CALGB 30506)
Purpose
Drugs used in chemotherapy, such as vinorelbine, cisplatin, docetaxel, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether chemotherapy is more effective than observation in treating patients who have undergone surgery for stage I non-small cell lung cancer.
This randomized phase III trial is studying three chemotherapy regimens to see how well they work compared with observation in treating patients with stage I non-small cell lung cancer.
Eligibility
Eligibility criteria include the following:
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At least 18 years old
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Cancer that has spread to other parts of the body
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More than 5 years since anticancer treatment for a different cancer
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Within two months after surgery to remove the tumor, patients will be randomly assigned to one of two treatment groups.
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In group one, some patients will receive an infusion of vinorelbine on days 1 and 8 and a 1-hour infusion of cisplatin on day 1. Other patients will receive 1-hour infusions of docetaxel and cisplatin on day 1. Other patients will receive an infusion of gemcitabine on days 1 and 8 and a 1-hour infusion of cisplatin on day 1. Treatment may repeat every 3 weeks for up to four courses.
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Patients in group two will receive observation as standard care.
Tissue samples collected during surgery will be examined in the laboratory.
After finishing treatment, patients will be evaluated every 4 months for 2 years and every 6 months for 3 years.
Whether the addition of CP 751,871 in combination with Paclitaxel plus Carboplatin prolongs survival in patients with advanced stage or metastatic non-small cell lung cancer (SLHN 2008-50; Pfizer A4021016 Lung)
Purpose
The purpose of this study is to determine whether the addition of CP 751,871 in combination with paclitaxel plus carboplatin prolongs survival in patients with advanced stage or metastatic (spreading) non-small cell lung cancer (NSCLC).
Eligibility Criteria
- Advanced NSCLC with documented Stage IIIB (with pleural effusion) or Stage IV or recurrent disease
- No prior treatment for advanced disease. Adjuvant (supplemental treatment post surgery in hopes of cure) chemotherapy is allowed. Adjuvant chemotherapy must have completed for greater than or equal to 12 months prior to patient assignment of study drug
- Prior surgery or radiation therapy is permitted if completed at least 3 weeks prior to patient assignment of study drug and all side effects of the radiation have resolved
- No spread of cancer to the brain which is causing symptoms
- Patients requiring chronic steroid use or patients with uncontrolled diabetes are not permitted
- No other active cancer types
Final eligibility is determined by the research staff.
Determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with advanced stage or metastatic non-small cell lung cancer (SLHN 2008-64; Novartis CASA404A2302 Lung)
Purpose
The purpose of this study is to determine if adding ASA404 to docetaxel chemotherapy makes the cancer treatment more effective in patients with advanced stage or metastatic (spreading) non-small cell lung cancer.
Eligibility Criteria
- Confirmed non-small cell carcinoma of the lung
- Progressed while on or following initial chemotherapy regimen for Stage IIIb disease or Stage IV disease. Patients who have received bevacizumab and/or EGFR inhibitors will be eligible
- 18 years of age or older
- Measurable or non-measurable disease on X-rays or scans
- Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by scans are allowed
- No history of another cancer in 5 years or less, with the exception of non-melanoma skin cancer or certain types of cervical cancer
- No radiotherapy 2 weeks or less prior to patient’s assignment to their study drug. Patients must have recovered from all radiotherapy-related side effects
- No major surgery 4 weeks or less or minor surgery 2 weeks or less prior to patient’s assignment to their study drug. Insertion of a vascular access device is allowed. Patients must have recovered from all surgery-related complications
- No chemotherapy regimen 3 weeks or less prior to patient’s assignment to their study drug
Final eligibility is determined by the research staff.
Phase III Randomized Study of High- Versus Standard-Dose Conformal Radiotherapy With Concurrent and Consolidation Chemotherapy Comprising Carboplatin and Paclitaxel in Patients With Newly Diagnosed, Unresectable Stage IIIA or IIIB Non-Small Cell Lung Cancer (RTOG 0617)
Purpose
Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy in treating patients with non-small cell lung cancer.
This randomized phase III trial is studying high-dose radiation therapy given together with chemotherapy to see how well it works compared with standard-dose radiation therapy and chemotherapy in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No distant metastases or Pancoast tumors
- Measurable disease
- At least 3 weeks since chest surgery
- No previous chemotherapy for non-small cell lung cancer
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will undergo low-dose radiation therapy 5 days-a-week for 6 weeks. They will also receive a one-hour infusion of paclitaxel and an infusion of carboplatin once-a-week in weeks 1-4 and 6 and twice in week 5.
- Patients in group two will undergo high-dose radiation therapy 5 days-a-week for 7 1/2 weeks. They will also receive a one-hour infusion of paclitaxel and an infusion of carboplatin once a week in weeks 1-4 and 6 and twice in week 5.
In week 10, patients will receive a 3-hour infusion of paclitaxel and an infusion of carboplatin. Treatment may repeat every 3 weeks for up to two courses.
Patients may undergo tumor tissue, blood, and urine collection periodically for laboratory studies.
Quality of life may be assessed at the beginning of the study and periodically during the study. After finishing treatment, patients will be evaluated periodically for 5 years and once-a-year thereafter.
Phase III Randomized Study of Lobectomy Versus Sublobar Resection in Patients With Small Peripheral Stage IA Non-Small Cell Lung Cancer (CALGB 140503)
Purpose
Wedge resection or segmentectomy may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.
This randomized phase III trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- No locally advanced or metastatic cancer
- No previous chemotherapy or radiation therapy for this cancer
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will undergo lobectomy by thoracotomy or video-assisted surgery.
- Patients in group two will undergo wedge resection or segmentectomy by thoracotomy or video-assisted surgery.
After finishing treatment, patients will be evaluated every three months for one year, every six months for one year, and once-a-year for up to five years.
Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (< 4cm) –IIIA Non-Small Cell Lung Cancer (NSCLC) (E1505)
Purpose
Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
This randomized phase III trial is studying chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- Has undergone surgery to completely remove the tumor within the past 6-12 weeks
- No previous chemotherapy
- More than five years since hormone therapy or radiation therapy for cancer
- More than four weeks since surgery or open biopsy
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.
- Patients in group one will receive one of three chemotherapy regimens. Some patients will receive an infusion of vinorelbine on days one and eight and a one-hour infusion of cisplatin on day one. Some patients will receive one-hour infusions of docetaxel and cisplatin on day one. Some patients will receive an infusion of gemcitabine on days one and eight and a one-hour infusion of cisplatin on day one. For all regimens, treatment may repeat every three weeks for up to four courses.
- Patients in group two will receive one of three chemotherapy regimens as in group one. They will also receive a 30- to 90-minute infusion of bevacizumab on day one. Treatment with bevacizumab may repeat every three weeks for up to one year.
Patients will complete questionnaires about smoking before beginning treatment and every three months during treatment. After finishing treatment, patients will be evaluated periodically for ten years.
Phase III randomized chemoprevention study of selenium in participants with previously resected stage I non-small cell lung cancer (ECOG 5597)
Purpose
Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known if selenium is effective in preventing the growth of new tumors in patients with previously resected non-small cell lung cancer.
Randomized phase III trial to determine the effectiveness of selenium in preventing the development of second primary lung tumors in patients who have undergone surgery to remove stage I non-small cell lung cancer.
Eligibility
Eligibility criteria include the following:
- At least 18 years old
- At least six months, but no more than three years, since surgery to remove lung tumors
- No evidence of lung cancer after surgery
- No previous chemotherapy or radiation therapy for lung cancer
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Treatment Intervention
Patients will be randomly assigned to one of two groups.
- Patients in group one will receive selenium by mouth once-a-day. Treatment may continue for up to four years.
- Patients in group two will receive a placebo by mouth once-a-day as in group one.
All patients will be evaluated once-a-year.