Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase III Study of Monotherapy by Gemcitabine or Vinorelbine Comparing to Doublet by Carboplatin and Paclitaxel Among Elderly Patients With Stage IIIB/IV NSCLC (Obligatory Second-line by Erlotinib)
Brief Summary: The last ASCO recommendations in 2003 for the treatment of a CBNPC of stage IIIB/IV of elderly people, are to manage a monochemotherapy. Paclitaxel in association with carboplatin is feasible in elderly patients and the retrospective analysis of two studies of the comparing SWOG, one this association with that of cisplatine and vinorelbine and the other cisplatine only with cisplatine and vinorelbine, showed among 117 the 70 years old patients and more, the absence of significant difference of survival and toxicity compared to the younger patients. The study recently published of Lilenbaum and Al shows that among patients with bad PS, association carboplatine and paclitaxel do better than the paclitaxel only. The paclitaxel managed in weekly form is likely of a better activity by exposing the cancerous cells in a repeated way with shorter intervals without allowing the emergence of resistant clones and by allowing an increase in the intensity of amount. This mode of administration appeared at the same time effective and tolerated very well among patients of more than 70 years. The weekly association of carboplatin and paclitaxel was tested in phase II and showed a rate of response of 14% and one survival 1 year from 31% a randomized test (not dedicated to the old person) of phase II to 3 arms was led by Belani et al.. The best combination of carboplatine + paclitaxel weekly proved to be that associating paclitaxel 100mg/m² 3 weeks out of 4 and carboplatine AUC 6 in J1 with J1 = J29. A test of phase II dedicated the 70 years old to patients and more was carried out in France taking again this association carboplatine (AUC 6) every 4 weeks and paclitaxel weekly (90 mg/m² J1, J8 and J15). This test having included 51 patients highlighted a median of 10,42 months survival (IC 95%: 7,29-17,05)


Options:
A: Inclusion Criteria:

* Pathologically / cytologically proven NSCLC stage IIIB or IV
* age \>= 70 years old and \< 90 years old
B: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed primary non-small cell lung cancer, including any of the following:

  * Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease
  * Newly diagnosed stage IV disease
  * Recurrent disease after prior surgery and/or radiotherapy
* Any of the following cellular subtypes are allowed:

  * Adenocarcinoma
  * Large cell carcinoma
  * Squamous cell carcinoma
  * Unspecified carcinoma
* Enrolled on protocol JMTO-LC00-03

PATIENT CHARACTERISTICS:

Performance status

* Zubrod 0-1

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY:

Radiotherapy

* See Disease Characteristics

Surgery

* See Disease Characteristics
C: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting criteria for 1 of the following:

  * Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease
  * Newly diagnosed stage IV disease
  * Recurrent disease after prior surgery and/or radiotherapy
* The following cellular subtypes are allowed:

  * Adenocarcinoma
  * Large cell carcinoma
  * Squamous cell carcinoma
  * Unspecified carcinoma
* Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical examination, or bone scintigraphy

  * Pleural effusions, ascites, and laboratory parameters are not allowed as the only evidence of disease
  * Disease must be present outside area of prior surgical resection
  * Disease must be present outside area of prior radiotherapy OR new lesion documented
* No known brain metastases by CT scan or MRI within the past 6 weeks
* No pleural or pericardial effusions requiring treatment

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* Zubrod 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9 g/dL

Hepatic

* Bilirubin ≤ 2 times upper limit of normal (ULN)
* SGOT or SGPT ≤ 2 times ULN
* Alkaline phosphatase ≤ 2 times ULN

Renal

* Creatinine ≤ ULN
* Creatinine clearance ≥ 50 mL/min

Cardiovascular

* No uncontrolled hypertension
* No unstable angina
* No congestive heart failure
* No myocardial infarction within the past year
* No ventricular arrhythmia requiring medical intervention

Other

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No prior allergic drug reaction attributed to Cremophor or polysorbate 80
* No disorder associated with lung cancer with life-threatening consequences
* No motor or sensory neuropathy ≥ grade 2
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
* No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No prior biologic therapy for NSCLC

Chemotherapy

* No prior systemic chemotherapy for NSCLC

Endocrine therapy

* No prior or concurrent steroid-type hormonal therapy (e.g., ethinyl estradiol)

Radiotherapy

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered

Surgery

* See Disease Characteristics
* At least 2 weeks since prior thoracic or other major surgery and recovered

Other

* No prior or concurrent azole antifungal therapy (e.g., ketoconazole, miconazole, or itraconazole)
* No prior or concurrent macrolides (e.g., erythromycin or clarithromycin)
* No prior or concurrent cyclosporine, terfenadine, benzodiazepines (e.g., diazepam, triazolam, or midazolam), or retinoids
* No prior or concurrent calcium antagonists (e.g., diltiazem, nifedipine, or verapamil)
D: DISEASE CHARACTERISTICS:

* Histologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following types:

  * Squamous cell
  * Adenocarcinoma
  * Large cell anaplastic
  * Bronchoalveolar
  * Non-small cell carcinoma not otherwise specified NOTE: Mixed tumors are categorized by the predominant cell type (tumors with small-cell anaplastic elements are ineligible)
* Evidence of at least 1 of the following:

  * Clinically documented recurrent disease after prior radiation or surgery
  * Stage IV disease (distant metastases)
  * Stage IIIB disease presenting with 1 of the following:

    * Pleural or pericardial effusion by CT scan or chest x-ray
    * Pleural implants documented pathologically or seen on CT scan or x-ray
* Measurable or evaluable disease
* No brain metastases unless clinically stable after surgery and/or radiotherapy

PATIENT CHARACTERISTICS:

Age

* 18 and over

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic

* Bilirubin no greater than 1.5 mg/dL
* AST less than 5 times upper limit of normal

Renal

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 40 mL/min

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No hypersensitivity to agents that contain Cremophor EL (polyoxyethylated castor oil)

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* No prior chemotherapy for advanced NSCLC

Endocrine therapy

* Not specified

Radiotherapy

* See Disease Characteristics
* Recovered from prior radiotherapy
* No prior radiotherapy to the only site of measurable disease, unless the site had subsequent progression of disease documented by physical exam, radiography, or pathology
* No concurrent radiotherapy (except for brain metastases)

Surgery

* See Disease Characteristics

Other

* No concurrent aminoglycoside antibiotics

Answer: A