S0022:Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

SWOG Cancer Research Network

Status and phase

Terminated

Phase 2

Conditions

Lung Cancer

Treatments

Drug: cisplatin

Drug: docetaxel

Radiation: radiation therapy

Study type

Interventional

Funder types

NETWORK

NIH

Identifiers

NCT00014196

S0022 (Other Identifier)

CDR0000068516

U10CA032102 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer.

Full description

OBJECTIVES:

Determine survival and time to treatment failure in patients with stage IIIB non-small cell lung cancer treated with induction docetaxel, cisplatin, and radiotherapy followed by consolidation docetaxel.
Determine the response rate in these patients when treated with this regimen.
Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 60 minutes on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy daily, 5 days per week, for 6.5 weeks.

At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy, patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed stage IIIB non-small cell lung cancer
- Adenocarcinoma
- Large cell carcinoma
- Squamous cell carcinoma
Pathologically or radiographically documented positive N3 nodes
- No positive supraclavicular or scalene lymph nodes with disease extending into the cervical region OR
T4 tumor invading any of the following:
- Mediastinum
- Heart
- Great vessels
- Trachea
- Esophagus
- Vertebral body
- Carina
No brain, contralateral chest, liver, or adrenal metastases
No more than 1 parenchymal lesion
No malignant pleural effusions unless they are only visible on CT scan or deemed too small to tap
No pericardial effusions
Measurable disease

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

Zubrod 0-2

Life expectancy:

Not specified

Hematopoietic:

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

Hepatic:

Not specified

Renal:

Creatinine clearance at least 50 mL/min

Pulmonary:

One of the following:
- FEV1 at least 2.0 L
- Predicted FEV1 of contralateral lung greater than 800 mL
- Predicted post-treatment FEV1 at least 1.0 L

Other:

No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent growth factors during induction chemoradiotherapy

Chemotherapy:

No prior chemotherapy for lung cancer

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy for lung cancer

Surgery:

No prior surgical resection of lung cancer
Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery for determining diagnosis, stage, or potential resectability allowed