This trial is active, not recruiting.

Condition lung cancer
Treatments carboplatin, cisplatin, gemcitabine hydrochloride
Phase phase 3
Sponsor Christie Hospital NHS Foundation Trust
Start date November 2002
End date August 2006
Trial size 400 participants
Trial identifier NCT00055965, CDR0000271903, CHNT-GEM-HOSP, EU-20245


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 if one regimen will require patients to spend more time in the hospital than the other regimen for treatment of chemotherapy-related side effects.

PURPOSE: Randomized phase III trial to compare the hospitalization rates of patients who are receiving gemcitabine combined with cisplatin with that of patients receiving gemcitabine combined with carboplatin for unresectable stage III or stage IV non-small cell lung cancer.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Rate of hospitalization due to toxicity
time frame:

Secondary Outcomes

Need for hospitalization for chemotherapy administration
time frame:
Tumor response rate
time frame:
Overall survival
time frame:
Relief of tumor-related symptoms
time frame:
Effect on Karnofsky performance status
time frame:
Toxicity as measured by NCIC CTC v2.0
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed inoperable non-small cell lung cancer - Stage IIIA, IIIB, or IV - Not eligible for curative radiotherapy or surgery - No symptomatic brain metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 50-100% Life expectancy - At least 12 weeks Hematopoietic - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 2,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST no greater than 2.5 times ULN - Alkaline phosphatase no greater than 3 times ULN (5 times ULN if liver metastases present) Renal - Creatinine no greater than ULN OR - Creatinine clearance at least 60 mL/min Other - Not pregnant or nursing - Fertile patients must use effective contraception during and for 3 months after study completion - No active infection - No serious systemic disorder that would preclude study participation - No grade 2 or greater peripheral neuropathy - No significant neurological problems (e.g., seizures or psychiatric disorders) - No other active malignancy within the past 5 years except carcinoma in situ of the cervix or adequately treated non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior cytotoxic chemotherapy - No other concurrent chemotherapy during or for 7 days after study therapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy - No concurrent radiotherapy during or for 7 days after study therapy Surgery - See Disease Characteristics Other - At least 12 weeks since prior investigational agents - No other concurrent antitumor therapy - No concurrent experimental medications

Additional Information

Official title A Pragmatic, Randomised Study To Compare The Hospitalisation Rates Of Two Platinum-Based Outpatient Regimens (Gemcitabine/Cisplatin vs. Gemcitabine/Carboplatin) In Non-Small Cell Lung Cancer (NSCLC)
Description OBJECTIVES: - Compare the rates of overnight hospitalization due to toxicity (e.g., blood transfusion, antibiotic use, and to obtain relief of treatment-related symptoms) of patients with non-small cell lung cancer treated with gemcitabine and cisplatin vs gemcitabine and carboplatin. - Compare the need for hospitalization for chemotherapy administration in patients treated with these regimens. - Compare the tumor response rate of patients treated with these regimens. - Compare the overall survival of patients treated with these regimens. - Compare the relief of tumor-related symptoms in patients treated with these regimens. - Compare the effect on Karnofsky performance status in patients treated with these regimens. - Compare the toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage (IIIA vs IIIB [dry] vs IIIB [wet] or IV) and performance status (50-60% vs 70-100%). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive gemcitabine IV over 30 minutes and cisplatin IV over 1-2 hours on days 1 and 8. - Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. In both arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 6 months and then every 3-4 months thereafter. PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).