NCT00026156

S0027: Vinorelbine Followed by Docetaxel in Treating Patients With Advanced Non-Small Cell Lung Cancer

Study Contact:

Study Phase:

PHASE2

Recruitment Status:

COMPLETED

NCT ID:

NCT00026156

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

Summary

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.

Eligibility

DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

Age:

* 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

Hematopoietic:

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

Hepatic:

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

Renal:

* Not specified

Other:

* 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior or concurrent biologic therapy for NSCLC
* No concurrent filgrastim (G-CSF)

Chemotherapy:

* No prior systemic chemotherapy for NSCLC

Endocrine therapy:

* No prior or concurrent hormonal therapy for NSCLC

Radiotherapy:

* 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

Surgery:

* See Disease Characteristics
* At least 3 weeks since prior thoracic or other major surgery and recovered

Disease(s) and\or Condition(s)

Lung Cancer

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: docetaxel
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: vinorelbine tartrate
- Description:
- Arm Group Labels:

Sponsor

SWOG Cancer Research Network