Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

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Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), May 2007
Sponsored by: University Hospital Birmingham

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00112710

Purpose
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether giving gemcitabine together with cisplatin is more effective than giving gemcitabine together with carboplatin in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying gemcitabine and cisplatin to see how well they work compared to gemcitabine and carboplatin in treating patients with stage III or stage IV non-small cell lung cancer.



Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: cisplatin
Drug: gemcitabine hydrochloride
Phase III




MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Cisplatin Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A British Thoracic Oncology Group Phase III Trial of Gemcitabine Plus Cisplatin at 80mg/m Versus Gemcitabine Plus Carboplatin At 50 mg/m Versus Gemcitabine Plus Carboplatin AUC 6 in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC)


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Length of survival [ Designated as safety issue: No ]



Secondary Outcome Measures:
Symptom control and quality of life as measured by the EORTC Quality of Life Questionnaire Core 30 Items and Lung Cancer supplement 13 together with EuroQol-5 domain questionnaire [ Designated as safety issue: No ]

Treatment response as measured by RECIST criteria [ Designated as safety issue: No ]

Dose intensity of chemotherapy [ Designated as safety issue: No ]

Ratio of treatment courses given as in-patient versus out-patient [ Designated as safety issue: No ]

Toxicity as measured by CTCAE v3.0 [ Designated as safety issue: Yes ]

Treatment cost [ Designated as safety issue: No ]


Estimated Enrollment: 1350
Study Start Date: March 2005
Detailed Description:
OBJECTIVES:

Primary

Compare the efficacy of gemcitabine in combination with 2 different doses of cisplatin vs carboplatin, in terms of survival time, in patients with stage IIIB or IV non-small cell lung cancer.
Secondary

Compare symptom control and quality of life of patients treated with these regimens.
Compare response in patients treated with these regimens.
Compare the dose intensity of these regimens in these patients.
Compare the ratio of courses of treatment given as in-patient vs out-patient in these patients.
Compare the intensity and number and duration of toxic episodes in patients treated with these regimens.
Compare cost and cost-effectiveness of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 or 2), disease stage (IIIB vs IV), and participating center. Patients are randomized to 1 of 3 treatment arms.

Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1.
Arm II: Patients receive gemcitabine as in arm I and cisplatin (at a lower dose than in arm I) IV over 1 hour on day 1.
Arm III: Patients receive gemcitabine as in arm I and carboplatin IV over 1 hour on day 1.
In all arms, treatment repeats every 21 days for 2 courses. Patients are reassessed after 2 courses. Patients with responding disease or stable disease with symptom improvement receive 2 additional courses of therapy in the absence of disease progression or unacceptable toxicity. Patients with disease progression or stable disease without symptom improvement are removed from the study.

Quality of life is assessed at baseline, on day 1 of courses 2-4, at completion of study treatment, and then monthly for 6 months.

After completion of study treatment, patients are followed monthly for 6 months and then periodically thereafter for survival.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 1,350 patients (450 per treatment arm) will be accrued for this study within 6 years.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:

Stage IIIB disease* that is not suitable for radical radiotherapy
Stage IV disease* NOTE: *Radiographically verified
At least 1 measurable lesion by clinical examination or radiography
No mixed histologies of small cell lung cancer and NSCLC
No clinically apparent brain metastases
PATIENT CHARACTERISTICS:

Age

18 and over
Performance status

WHO 0-2
Life expectancy

At least 12 weeks
Hematopoietic

WBC ≥ 3,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 10 g/dL
Hepatic

AST < 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
Alkaline phosphatase < 3 times ULN
Bilirubin < 1.5 times ULN
Renal

Creatinine clearance &#8805; 60 mL/min (by Wright equation) OR &#8805; 70 mL/min (by ^51Cr-EDTA clearance)
Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able and willing to participate in the quality of life assessment
No pre-existing neuropathy > grade 2
No other malignancy that would preclude study treatment or study comparisons
No evidence of severe or uncontrolled systemic disease, significant clinical disorder, or laboratory finding that would preclude study participation
No psychiatric disorder that would preclude study participation
No other condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:

Biologic therapy

No concurrent immunotherapy
Chemotherapy

No prior chemotherapy, including neoadjuvant or adjuvant chemotherapy
No other concurrent cytotoxic chemotherapy
Endocrine therapy

No concurrent hormonal therapy except contraceptives or replacement steroids
Radiotherapy

No prior radiotherapy
Surgery

Recovered from prior surgery
Prior surgical resection for NSCLC allowed
Other

More than 12 weeks since prior investigational agents and recovered
No other concurrent specific antitumor therapy
No other concurrent investigational agents
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112710


Locations
United Kingdom, England
Birmingham Heartlands Hospital Recruiting
Birmingham, England, United Kingdom, B9 5SS
Contact: Joyce Thompson 44-121-766-6611
Institute of Clinical Research - Birmingham Recruiting
Birmingham, England, United Kingdom, B15 2TT
Contact: Hugh Jarrett 44-121-414-6425

Sponsors and Collaborators
University Hospital Birmingham
Investigators
Study Chair: Hugh Jarrett Institute of Clinical Research - Birmingham

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000429610, CRUK-BTOG2-LU3005, EU-20510
Study First Received: June 2, 2005
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00112710 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer



Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carboplatin
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma



Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms by Site
Neoplasms
Neoplasms by Histologic Type
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses



ClinicalTrials.gov processed this record on February 10, 2009


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