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

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ClinicalTrials.gov Identifier: NCT00006004

Recruitment Status : Completed

First Posted : January 27, 2003

Last Update Posted : August 20, 2013

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by:

Eastern Cooperative Oncology Group

Tracking Information

First Submitted Date ^ICMJE

July 5, 2000

First Posted Date ^ICMJE

January 27, 2003

Last Update Posted Date

August 20, 2013

Study Start Date ^ICMJE

May 2000

Actual Primary Completion Date

January 2005 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Primary Purpose: Treatment

Condition ^ICMJE

Lung Cancer

Intervention ^ICMJE

Drug: carboplatin
Drug: cisplatin
Drug: gemcitabine hydrochloride
Drug: paclitaxel

Study Arms ^ICMJE

Not Provided

Publications *

Langer C, Li S, Schiller J, Tester W, Rapoport BL, Johnson DH; Eastern Cooperative Oncology Group. Randomized phase II trial of paclitaxel plus carboplatin or gemcitabine plus cisplatin in Eastern Cooperative Oncology Group performance status 2 non-small-cell lung cancer patients: ECOG 1599. J Clin Oncol. 2007 Feb 1;25(4):418-23.
Tester WJ, Stephenson P, Langer CJ, et al.: ECOG 1599: randomized phase II study of paclitaxel/carboplatin or gemcitabine/cisplatin in performance status (PS) 2 patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 22 (Suppl 14): A-7055, 630s, 2004.
Langer CJ, Stephenson P, Schiller J, et al.: ECOG 1599: randomized phase II study of paclitaxel/carboplatin vs cisplatin/gemcitabine in performance status (PS) 2 patients with treatment-naive advanced NSCLC. [Abstract] Lung Cancer 41 (Suppl 2): A-O52, S18, 2003.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Original Enrollment ^ICMJE

Not Provided

Study Completion Date ^ICMJE

Not Provided

Actual Primary Completion Date

January 2005 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia, Peru, Puerto Rico, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00006004

Other Study ID Numbers ^ICMJE

CDR0000068012
E-1599

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Corey J. Langer, MD

Fox Chase Cancer Center

PRS Account

Eastern Cooperative Oncology Group

Verification Date

August 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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