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Phase II Trial of Sequential Vinorelbine and Docetaxel in Advanced Non-Small Cell Lung Cancer Patients Age Seventy and Older, or With Performance Status 2

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Trial Conditions
  • Lung Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of vinorelbine followed by docetaxel in treating patients who have advanced non-small cell lung cancer.

Date & Status


Who can Participate?


18 and older




- Histologically or cytologically confirmed, newly diagnosed, advanced primary
non-small cell lung cancer (NSCLC) (adenocarcinoma, large cell carcinoma, squamous
cell carcinoma, or unspecified), designated as 1 of the following stages:

- Selected stage IIIB (excluding Pancoast tumors)

- T4 lesion due to malignant pleural effusion OR

- Multiple lesions in a single lobe containing a T3 or T4 primary

- Stage IV (any T, any N, M1)

- Recurrent disease after prior surgery and/or radiotherapy

- Measurable or evaluable disease outside of prior radiation port

- No bronchoalveolar carcinoma

- No brain metastases



- 18 and over

Performance status:

- Zubrod 0-1 (for age 70 and over) (Age 70 and older with Zubrod 0-1 stratum closed to
accrual as of 2/15/2003)

- Zubrod 2 (for age 18 and over)

Life expectancy:

- Not specified


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than upper limit of normal (ULN)

- SGOT/SGPT no greater than 2 times ULN if alkaline phosphatase is no greater than ULN

- Alkaline phosphatase no greater than 4 times ULN if SGOT/SGPT are no greater than ULN


- Not specified


- No prior severe hypersensitivity to docetaxel or other drugs formulated with
polysorbate 80

- No grade 2 or greater sensory neuropathy

- 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 other adequately
treated stage I or II cancer in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- No prior or concurrent biologic therapy for NSCLC

- No concurrent filgrastim (G-CSF)


- No prior systemic chemotherapy for NSCLC

Endocrine therapy:

- No prior or concurrent hormonal therapy for NSCLC


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- Concurrent palliative radiotherapy to small-field nonmeasurable lesions (i.e.,
painful bony lesions) allowed

- No other concurrent radiotherapy


- See Disease Characteristics

- At least 3 weeks since prior thoracic or other major surgery and recovered

Gender: Both
Steward Physician(s)
  • Paul J. Hesketh, MD
Trial Interventions
  • docetaxel
  • vinorelbine tartrate
Physician Researcher

Investigator Name:

  • Paul J. Hesketh, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 2
Trial ID: NCT00026156
Volunteers:  Not Accepting Healthy Volunteers

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