Combination Chemotherapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

A Randomized, Phase III Multicenter Trial Of Gemcitabine In Combination With Carboplatin Or Paclitaxel Plus Carboplatin In Patients With Metastatic (Stage IIIB, IV) Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00054392
• Other study ID #: ALPHA-A1-99002L
• Secondary ID: CDR0000270434
• Status: Withdrawn
• Phase: Phase 3
• First received: February 5, 2003
• Last updated: July 10, 2013
• Start date: September 2001
• Est. completion date: September 2001

Study information

• Verified date: July 2013
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy such as gemcitabine, carboplatin, and paclitaxel 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 chemotherapy regimen is more effective in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Description:

OBJECTIVES:

• Compare the overall survival of patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with gemcitabine and carboplatin vs gemcitabine and paclitaxel vs paclitaxel and carboplatin.

• Compare the overall response rate and time to progression in patients treated with these regimens.

• Compare the toxic effects of these regimens in these patients.

• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to weight loss within the past 6 months (less than 5% vs at least 5%), disease stage (IIIB vs IV), and brain metastases (present vs absent). Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 15-30 minutes on day 1.

• Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and paclitaxel IV over 3 hours on day 1.

• Arm III: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1.

In all arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 6 weeks during study treatment, and then every 3 months until progressive disease is documented.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 1,134 patients (378 per treatment arm) will be accrued for this study within 2 years.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2001
• Est. primary completion date: September 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed non-small cell lung cancer (NSCLC) of 1 of the following types:

• Squamous cell

• Adenocarcinoma

• Large cell anaplastic

• Bronchoalveolar

• Non-small cell carcinoma not otherwise specified NOTE: Mixed tumors are categorized by the predominant cell type (tumors with small-cell anaplastic elements are ineligible)

• Evidence of at least 1 of the following:

• Clinically documented recurrent disease after prior radiation or surgery

• Stage IV disease (distant metastases)

• Stage IIIB disease presenting with 1 of the following:

• Pleural or pericardial effusion by CT scan or chest x-ray

• Pleural implants documented pathologically or seen on CT scan or x-ray

• Measurable or evaluable disease

• No brain metastases unless clinically stable after surgery and/or radiotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count at least 1,500/mm^3

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

Hepatic

• Bilirubin no greater than 1.5 mg/dL

• AST less than 5 times upper limit of normal

Renal

• Creatinine no greater than 1.5 mg/dL OR

• Creatinine clearance at least 40 mL/min

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No hypersensitivity to agents that contain Cremophor EL (polyoxyethylated castor oil)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for advanced NSCLC

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

• Recovered from prior radiotherapy

• No prior radiotherapy to the only site of measurable disease, unless the site had subsequent progression of disease documented by physical exam, radiography, or pathology

• No concurrent radiotherapy (except for brain metastases)

Surgery

• See Disease Characteristics

Other

• No concurrent aminoglycoside antibiotics

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• gemcitabine hydrochloride

• paclitaxel

Locations

Country	Name	City	State
United States	Rosenfeld Cancer Center at Abington Memorial Hospital	Abington	Pennsylvania
United States	Annapolis Oncology Center	Annapolis	Maryland
United States	Greater Baltimore Medical Center Cancer Center	Baltimore	Maryland
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Aultman Hospital Cancer Center at Aultman Health Foundation	Canton	Ohio
United States	Falling Spring Medical Associates	Chambersburg	Pennsylvania
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina
United States	David Lee Outpatient Cancer Center at Charleston Area Medical Center	Charleston	West Virginia
United States	University of Virginia Cancer Center at UV Health System	Charlottesville	Virginia
United States	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Family Cancer Center, PLLC - Collierville	Collierville	Tennessee
United States	South Carolina Oncology Associates, PA	Columbia	South Carolina
United States	Veterans Affairs Medical Center - Atlanta (Decatur)	Decatur	Georgia
United States	Hematology-Oncology Associates of Northeastern Pennsylvania	Dunmore	Pennsylvania
United States	Cape Fear Valley Medical Center	Fayetteville	North Carolina
United States	Hunterdon Regional Cancer Center at Hunterdon Medical Center	Flemington	New Jersey
United States	University of Florida Shands Cancer Center	Gainesville	Florida
United States	Sletten Regional Cancer Institute at Benefis Healthcare	Great Falls	Montana
United States	Leo W. Jenkins Cancer Center at ECU Medical School	Greenville	North Carolina
United States	PinnacleHealth Regional Cancer Center at Polyclinic Hospital	Harrisburg	Pennsylvania
United States	Ingalls Cancer Care Center at Ingalls Memorial Hospital	Harvey	Illinois
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Richard G. Laube Cancer Center at ACMH	Kittanning	Pennsylvania
United States	Baptist Regional Cancer Center at Baptist Hospital of East Tennessee	Knoxville	Tennessee
United States	Lakeland Regional Cancer Center at Lakeland Regional Medical Center	Lakeland	Florida
United States	Lancaster Cancer Center	Lancaster	Pennsylvania
United States	Central Pennsylvania Hematology and Medical Oncology Associates, PC	Lemoyne	Pennsylvania
United States	Loma Linda University Cancer Institute at Loma Linda University Medical Center	Loma Linda	California
United States	Mary Babb Randolph Cancer Center at West Virginia University Hospitals	Morgantown	West Virginia
United States	Morgantown Internal Medicine Group, Incorporated	Morgantown	West Virginia
United States	Coastal Cancer Center - Myrtle Beach	Myrtle Beach	South Carolina
United States	Jersey Shore Cancer Center at Jersey Shore University Medical Center	Neptune	New Jersey
United States	Cancer Center of Indiana	New Albany	Indiana
United States	Lawrence and Memorial Hospital	New London	Connecticut
United States	Gulf Coast Cancer Treatment Center	Panama City	Florida
United States	Paoli Hematology-Oncology PC at Paoli Memorial Hospital	Paoli	Pennsylvania
United States	Parma Community General Hospital	Parma	Ohio
United States	Drexel University College of Medicine - Center City Hahnemann Campus	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center CCOP Research Base	Philadelphia	Pennsylvania
United States	Hahnemann University Hospital	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia	Philadelphia	Pennsylvania
United States	Allegheny Cancer Center at Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Hillman Cancer Center at University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey
United States	New Hope Cancer and Research Institute - Pomona	Pomona	California
United States	Pottstown Memorial Regional Cancer Center	Pottstown	Pennsylvania
United States	St. Joseph Medical Center	Reading	Pennsylvania
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	Baystate Regional Cancer Program at D'Amour Center for Cancer Care	Springfield	Massachusetts
United States	Mercer Bucks Oncology-Hematology	Trenton	New Jersey
United States	Carle Cancer Center at Carle Foundation Hospital	Urbana	Illinois
United States	Fallon Clinic at Worcester Medical Center	Worcester	Massachusetts
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Edelman MJ, Belani CP, Socinski MA, Ansari RH, Obasaju CK, Chen R, Monberg MJ, Treat J; Alpha Oncology Research Network. Outcomes associated with brain metastases in a three-arm phase III trial of gemcitabine-containing regimens versus paclitaxel plus car — View Citation

Obasaju CK, Ansari RH, Socinski MA, Chen R, Monberg MJ, Catalano RB, Marinucci DM, Liles DK, Ribeiro MJ, Comis RL, Treat J; Alpha Oncology Research Network. A Comparison of white and African American outcomes from a three-arm, randomized, phase III multic — View Citation

Treat J, Belani CP, Edelman MJ, et al.: A randomized phase III trial of gemcitabine (G) in combination with carboplatin (C) or paclitaxel (P) versus paclitaxel plus carboplatin in advanced (Stage IIIB, IV) non-small cell lung cancer (NSCLC): update of the

Treat J, Edelman MJ, Belani CP, Socinski MA, Monberg MJ, Chen R, Obasaju CK; Alpha Oncology Research Network. A retrospective analysis of outcomes across histological subgroups in a three-arm phase III trial of gemcitabine in combination with carboplatin — View Citation

Treat JA, Gonin R, Socinski MA, Edelman MJ, Catalano RB, Marinucci DM, Ansari R, Gillenwater HH, Rowland KM, Comis RL, Obasaju CK, Belani CP; Alpha Oncology Research Network. A randomized, phase III multicenter trial of gemcitabine in combination with car — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival			No
Secondary	Tumor response rate			No
Secondary	Time to disease progression			No
Secondary	Quality of life as measured by the Functional Assessment of Cancer -Lung (FACT-L) questionnaire at baseline, every 6 weeks during study treatment, and then every 3 months thereafter			No