Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00006004

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for treating non-small cell lung cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have non-small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin Drug: cisplatin Drug: gemcitabine hydrochloride Drug: paclitaxel	Phase 2

Detailed Description

OBJECTIVES:

Compare overall survival, response rate, and time to progression of patients with non-small cell lung cancer treated with paclitaxel and carboplatin versus gemcitabine and cisplatin.
Compare the toxicities of each of these 2 regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss in the past 6 months (less than 5% vs at least 5%) and disease stage (stage IIIB with pleural or pericardial effusion or pleural implants vs stage IV/recurrent). Patients are randomized to one of two treatment arms.

Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 15-30 minutes on day 1.
Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1 only.

Treatment continues in both arms every 21 days for up to 6 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 40-90 patients (20-45 per arm) will be accrued for this study within 12 months.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients

Study Start Date :

May 1, 2000

Actual Primary Completion Date :

Jan 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung carcinoma of any of the following subtypes:
Squamous cell
Adenocarcinoma
Large cell anaplastic
Bronchioalveolar
Non-small cell carcinoma not otherwise specified
No small cell anaplastic elements allowed
Must have:
Recurrent disease after prior radiotherapy or surgery OR
Stage IV disease with distant metastases OR
Stage IIIB disease presenting with pleural or pericardial effusion on CT or chest x-ray or pleural implants documented pathologically or on CT or chest x-ray
Bidimensionally measurable or evaluable disease
Brain metastases allowed provided clinically stable after treatment with surgery and/or radiotherapy

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 2

Life expectancy:

Not specified

Hematopoietic:

Absolute neutrophil count at least 1,500/mm3
Platelet count at least 100,000/mm3

Hepatic:

Bilirubin no greater than 1.5 mg/dL
SGOT no greater than 5 times upper limit of normal

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min

Cardiovascular:

No uncontrolled high blood pressure, unstable angina, or congestive heart failure
No myocardial infarction within the past 6 months
No serious ventricular arrhythmias requiring medication

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No other active malignancies requiring ongoing treatment
No uncontrolled serious active infections
No suspected hypersensitivity to agents that utilize Cremophor
No evidence of neuropathy grade 2 or greater by history or physical examination

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for non-small cell lung cancer

Endocrine therapy:

Not specified

Radiotherapy:

See Disease Characteristics
No prior radiotherapy to only site of measurable or evaluable disease unless subsequent progression documented by physical exam, radiograph, or pathology
Recovered from prior radiotherapy
No concurrent radiotherapy except for whole brain radiation for developing brain metastases

Surgery:

See Disease Characteristics

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Hospital - Atlanta	Atlanta	Georgia	United States	30322
2	Iowa Methodist Medical Center	Des Moines	Iowa	United States	50309
3	Mercy Medical Center	Des Moines	Iowa	United States	50314
4	Iowa Lutheran Hospital	Des Moines	Iowa	United States	50316-2301
5	Alegent Health-Midlands Community Hospital	Papillion	Nebraska	United States	68128-4157
6	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
7	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
8	MBCCOP - University of New Mexico HSC	Albuquerque	New Mexico	United States	87131
9	James P. Wilmot Cancer Center	Rochester	New York	United States	14642
10	CCOP - Oklahoma	Tulsa	Oklahoma	United States	74136
11	Milton S. Hershey Medical Center	Hershey	Pennsylvania	United States	17033-0850
12	CCOP - Scott and White Hospital	Temple	Texas	United States	76508
13	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin	United States	54307-3453
14	Westmead Hospital	Westmead	New South Wales	Australia	2145
15	Instituto de Enfermedades Neoplasicas	Lima		Peru	34
16	San Juan City Hospital	San Juan		Puerto Rico	00936-7344