Lung CancerPhase 2NCT00006004
Comparison of Two Combination Chemotherapy Regimens in Treating Non-small Cell Lung Cancer
A Phase 2 study testing carboplatin, cisplatin and gemcitabine hydrochloride in people with Lung Cancer, run by Eastern Cooperative Oncology Group at 16 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- carboplatin, cisplatin and gemcitabine hydrochloride
- How many people
- Not given
- Where
- 16 sitesin 4 countries
- Study dates
- 22 Aug 2000to Jan 2005
- Phase
- Phase 2
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
16 sites in 4 countries.
16 sites in 4 countries
United States13 sites
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, 87131
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Mercy Medical Center
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316-2301
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Alegent Health-Midlands Community Hospital
Papillion, Nebraska, 68128-4157
James P. Wilmot Cancer Center
Rochester, New York, 14642
CCOP - Scott and White Hospital
Temple, Texas, 76508
CCOP - Oklahoma
Tulsa, Oklahoma, 74136
About this study
Official title: A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- carboplatin, cisplatin, gemcitabine hydrochloride, paclitaxel
- Keywords
- recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboplatinDrug
cisplatinDrug
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start22 Aug 2000
- Primary completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Corey J. Langer, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006004
- Sponsor's protocol ID
- CDR0000068012
- Other IDs
- E-1599
- Status last verified
- Jun 2023
- First submitted
- 5 Jul 2000
- Last updated
- 15 Jun 2023
- Results posted
- No
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. doi: 10.1200/JCO.2005.04.9452.
PubMed 17264337Tester 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Paclitaxel-Carboplatin or Gemicitabine-Cisplatin in ECOG Performance Status 2 Non-Small Cell Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT00006004
- Acronym / sponsor ID
- CDR0000068012
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 22 Aug 2000 (actual)
- Primary completion
- Jan 2005 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| carboplatin | Drug | – |
| cisplatin | Drug | – |
| gemcitabine hydrochloride | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Results publication: PubMed 17264337Langer 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. doi: 10.1200/JCO.2005.04.9452.
- Results publicationTester 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.
- Results publicationLanger 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey J. Langer, MD study chair
Fox Chase Cancer Center
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing carboplatin, cisplatin and gemcitabine hydrochloride in people with Lung Cancer, run by Eastern Cooperative Oncology Group at 16 sites in 4 countries.
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: finished, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia, Peru, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006004, which also lists 3 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 15 Jun 2023.