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Active Clinical Trials > Cancer Treatment and Symptom Management Trials |
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Active Clinical Trials: Lung- Non-Small Cell Lung Cancer
| Protocol | Title |
| NCCTG-N0321 | Phase I/II Study of PS-341 in Combination with Paclitaxel, Carboplatin, and Concurrent Thoracic Radiation Therapy for Non-small Cell Lung Cancer (NSCLC) (1156) |
| SWOG-S0709 | A Phase II Selection Design of Pharmacodynamic Separation of Carboplatin/Paclitaxel/OSI-774 (Erlotinib; NSC-718781) or OSI-774 Alone in Advanced Non-Small Cell Lung Cancer (NSCLC) Patients with Performance Status 2 (PS-2) Selected by Serum Proteomics. (1649)-
Eligibility: click to view information
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following subtypes:
Adenocarcinoma
Large cell carcinoma
Squamous cell carcinoma
Unspecified
Newly diagnosed primary disease OR recurrent disease after prior surgery and/or radiotherapy, meeting 1 of the following staging criteria:
Selected stage IIIB disease (T4 [secondary to malignant pleural effusion only], any N, M0)
Stage IV disease (any T, any N, M1 [distant metastases present])
Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical exam, or nuclear scan
The CT scan from a combined PET/CT scan may only be used to document nonmeasurable disease
Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
Shows evidence of EGFR tyrosine kinase inhibitor therapy benefit (i.e., "proteomics positive") prior to study registration
No known brain metastases by CT scan or MRI of the brain
PATIENT CHARACTERISTICS:
Zubrod performance status 2
ANC e 1,500/mm³
Platelet count e 1,000/mm³
Serum bilirubin normal
SGOT or SGPT normal
Serum creatinine d 2 times upper limit of normal OR creatinine clearance e 50 mL/min
Willing to provide prior smoking history as requested on the prestudy form
No gastrointestinal (GI) tract disease resulting in an inability to take enteral medication
No malabsorption syndrome or requirement for IV alimentation
No uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis)
No significant history of cardiac disease, including any of the following:
Uncontrolled high blood pressure
Unstable angina
Congestive heart failure
Myocardial infarction within the past 6 months
Cardiac ventricular arrhythmia requiring medication
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 3 weeks since prior radiotherapy or surgery (thoracic or other major surgery) and recovered
At least 1 year since prior adjuvant chemotherapy
No prior systemic hormonal therapy, chemotherapy, or biological therapy for advanced NSCLC
No prior EGFR inhibitors
No prior surgical procedures affecting absorption
No concurrent major surgery
- Consent Forms: S0709 Consent
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| SWOG-S0819 | A Randomized, Phase III Study Comparing Carboplatin/Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or without Concurrent Cetuximab in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) (1728)-
Eligibility: click to view information
**see section 19.6, sub section 2.0, regarding mandatory electronic scan submission & to download computer application**
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer, including any of the following subtypes:
Adenocarcinoma
Large cell carcinoma
Squamous cell carcinoma
Unspecified
Newly diagnosed stage IV disease OR recurrent disease after prior surgery and/or irradiation
Patients with additional lesions in an ipsilateral non-primary lobe without M1a or M1b disease are not considered to have stage IV disease and are not eligible
Measurable or non-measurable disease documented by CT scan or MRI
Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease
Measurable disease must be outside a previously irradiated field or must have progressed
Brain metastases allowed provided they have been controlled for = 2 months after completion of treatment and there is no residual neurological dysfunction while off corticosteroids
PATIENT CHARACTERISTICS:
Zubrod performance status 0-1
ANC = 1,500/mm^3
Platelet count = 100,000/mm^3
Hemoglobin = 9 g/dL
Serum creatinine normal
Creatinine clearance = 50 mL/min
Urine protein:creatinine ratio = 0.5 OR 24-hour urine protein < 1,000 mg
Serum bilirubin = 2 times upper limit of normal (ULN) (= 5 times ULN for patients with liver metastases)
SGOT OR SGPT = 2 times ULN (= 5 times ULN for patients with liver metastases)
Not pregnant or nursing
Fertile patients must use effective contraception during and for 3-6 months after completion of study treatment
Agrees to submission of specimens for EGFR FISH testing and other translational medicine studies
Willing to provide prior smoking history
No significant traumatic injury within the past 28 days
No symptomatic sensory neuropathy = grade 2 as assessed by NCI CTCAE v3.0
No documented presence of human anti-mouse antibodies
No documented evidence of acute hepatitis
No active or uncontrolled infection
None of the following within the past 6 months:
Cerebrovascular accident, myocardial infarction, or unstable angina
Uncontrolled hypertension
NYHA class II-IV congestive heart failure
Serious cardiac arrhythmia requiring medication
Clinically significant peripheral vascular disease
No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (e.g., trastuzumab [Herceptin®] or epoetin alpha)
No other prior malignancy except for any of the following:
Adequately treated basal cell or squamous cell skin cancer
In situ cervical cancer
Adequately treated stage I or II cancer from which the patient is currently in complete remission
Any other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Prior radiotherapy allowed provided patients have recovered from all associated toxicities at the time of study registration
No prior chemotherapy, cetuximab, gefitinib, erlotinib, or other investigational agents that target the EGFR pathway
No prior VEGF-related agents
No prior chimerized or murine monoclonal antibody therapy
At least 28 days since prior surgery (thoracic or other major surgeries) or open biopsy and recovered
More than 7 days since prior core biopsy
No concurrent major surgical procedures
- Consent Forms: S0819 NCI Consent
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