Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin

NCT ID: NCT00055965

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-11-30

Brief 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 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.

Detailed 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.

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

carboplatin

Intervention Type: DRUG

cisplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Christie NHS Foundation Trust

OTHER

Sponsor Role: lead

Principal Investigators

Nick Thatcher, PhD, FRCP

Role: STUDY_CHAIR

The Christie NHS Foundation Trust

Locations

Christie Hospital NHS Trust

Manchester, England, United Kingdom

Countries

United Kingdom

Other Identifiers

CHNT-GEM-HOSP

Identifier Type: -

Identifier Source: secondary_id

EU-20245

Identifier Type: -

Identifier Source: secondary_id

CDR0000271903

Identifier Type: -

Identifier Source: org_study_id