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AzTrials

Lung CancerPhase 3NCT00054392

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

A Phase 3 study testing carboplatin, gemcitabine hydrochloride and paclitaxel in people with Lung Cancer, run by Fox Chase Cancer Center at 57 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, gemcitabine hydrochloride and paclitaxel
How many people
0 participants
Where
57 sitesUnited States
Study dates
Sep 2001to Sep 2001
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

57 sites in 1 country.

57 sites in 1 country

United States57 sites

  • Rosenfeld Cancer Center at Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Annapolis Oncology Center

    Annapolis, Maryland, 21401

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center Cancer Center

    Baltimore, Maryland, 21204

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710-1799

  • Falling Spring Medical Associates

    Chambersburg, Pennsylvania, 17201

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • David Lee Outpatient Cancer Center at Charleston Area Medical Center

    Charleston, West Virginia, 25304-1297

  • University of Virginia Cancer Center at UV Health System

    Charlottesville, Virginia, 22908

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Family Cancer Center, PLLC - Collierville

    Collierville, Tennessee, 38077

  • South Carolina Oncology Associates, PA

    Columbia, South Carolina, 29210

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia, 30033

  • Hematology-Oncology Associates of Northeastern Pennsylvania

    Dunmore, Pennsylvania, 18512

  • Cape Fear Valley Medical Center

    Fayetteville, North Carolina, 28302-2000

  • Hunterdon Regional Cancer Center at Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0383

  • Sletten Regional Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Leo W. Jenkins Cancer Center at ECU Medical School

    Greenville, North Carolina, 27834

  • PinnacleHealth Regional Cancer Center at Polyclinic Hospital

    Harrisburg, Pennsylvania, 17110

  • Ingalls Cancer Care Center at Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Study site

    Howell Township, New Jersey, 07731

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Richard G. Laube Cancer Center at ACMH

    Kittanning, Pennsylvania, 16201

  • Baptist Regional Cancer Center at Baptist Hospital of East Tennessee

    Knoxville, Tennessee, 37901

  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center

    Lakeland, Florida, 33805

  • Lancaster Cancer Center

    Lancaster, Pennsylvania, 17605-0396

  • Central Pennsylvania Hematology and Medical Oncology Associates, PC

    Lemoyne, Pennsylvania, 17043

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Morgantown Internal Medicine Group, Incorporated

    Morgantown, West Virginia, 26505

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9162

  • Coastal Cancer Center - Myrtle Beach

    Myrtle Beach, South Carolina, 29572

  • Jersey Shore Cancer Center at Jersey Shore University Medical Center

    Neptune City, New Jersey, 07754

  • Cancer Center of Indiana

    New Albany, Indiana, 47150

  • Lawrence and Memorial Hospital

    New London, Connecticut, 06320

  • Gulf Coast Cancer Treatment Center

    Panama City, Florida, 32405-4587

  • Paoli Hematology-Oncology PC at Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Parma Community General Hospital

    Parma, Ohio, 44129

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania, 19102-1192

  • Drexel University College of Medicine - Center City Hahnemann Campus

    Philadelphia, Pennsylvania, 19102

  • Fox Chase Cancer Center CCOP Research Base

    Philadelphia, Pennsylvania, 19104-4283

  • Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia

    Philadelphia, Pennsylvania, 19106

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Allegheny Cancer Center at Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212-4772

  • Hillman Cancer Center at University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • New Hope Cancer and Research Institute - Pomona

    Pomona, California, 91767

  • AtlantiCare Regional Medical Center

    Pomona, New Jersey, 08240

  • Pottstown Memorial Regional Cancer Center

    Pottstown, Pennsylvania, 19464

  • St. Joseph Medical Center

    Reading, Pennsylvania, 19603

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Baystate Regional Cancer Program at D'Amour Center for Cancer Care

    Springfield, Massachusetts, 01107

  • Mercer Bucks Oncology-Hematology

    Trenton, New Jersey, 08618

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Fallon Clinic at Worcester Medical Center

    Worcester, Massachusetts, 01608

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Lung Cancer
Keywords
adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, large cell lung cancer, recurrent non-small cell lung cancer, squamous cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung
Medical subject headings
Lung Neoplasms, Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

Secondary outcomes (3)

  1. Tumor response rate

  2. Time to disease progression

  3. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2003 (estimated)
  2. Study startSep 2001
  3. Primary completionSep 2001
  4. Study completionSep 2001

Why it stopped: Not opened at Fox Chase Cancer Center

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00054392
Sponsor's protocol ID
ALPHA-A1-99002L
Other IDs
CDR0000270434
Status last verified
Jul 2013
First submitted
5 Feb 2003
Last updated
11 Jul 2013
Results posted
No

Publications

  • 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 carboplatin for advanced non-small cell lung cancer. J Thorac Oncol. 2010 Jan;5(1):110-6. doi: 10.1097/JTO.0b013e3181c59a3a.

    PubMed 20035187

  • 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 multicenter trial of advanced or metastatic non-small cell lung cancer. J Thorac Oncol. 2010 Jul;5(7):993-1000. doi: 10.1097/jto.0b013e3181e29cf3.

    PubMed 20593535

  • 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 carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2010 Mar;21(3):540-547. doi: 10.1093/annonc/mdp352. Epub 2009 Oct 15.

    PubMed 19833819

  • 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 or paclitaxel versus paclitaxel plus carboplatin for advanced non-small cell lung cancer. Lung Cancer. 2010 Dec;70(3):340-6. doi: 10.1016/j.lungcan.2010.02.011. Epub 2010 Mar 27.

    PubMed 20347506

  • 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 Alpha Oncology trial (A1-99002L). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA7025, 627s, 2005.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing carboplatin, gemcitabine hydrochloride and paclitaxel in people with Lung Cancer, run by Fox Chase Cancer Center at 57 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00054392, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.

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