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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)


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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)


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Rate of hospitalization due to toxicity

Safety Issue:

Yes

Principal Investigator

Nick Thatcher, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Christie Hospital NHS Foundation Trust

Authority:

United States: Federal Government

Study ID:

CDR0000271903

NCT ID:

NCT00055965

Start Date:

November 2002

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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