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

Sponsor:	Christie Hospital NHS Foundation Trust
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055965

Purpose

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.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Carboplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Rate of hospitalization due to toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Need for hospitalization for chemotherapy administration [ Designated as safety issue: No ]
Tumor response rate [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Relief of tumor-related symptoms [ Designated as safety issue: No ]
Effect on Karnofsky performance status [ Designated as safety issue: No ]
Toxicity as measured by NCIC CTC v2.0 [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	November 2002
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

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.

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055965

Locations

United Kingdom, England
Christie Hospital NHS Trust
Manchester, England, United Kingdom, M20 4BX

Sponsors and Collaborators

Christie Hospital NHS Foundation Trust

Investigators

Study Chair:

Nick Thatcher, PhD, FRCP

Christie Hospital NHS Foundation Trust

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000271903, CHNT-GEM-HOSP, EU-20245
Study First Received:	March 6, 2003
Last Updated:	January 24, 2009
ClinicalTrials.gov Identifier:	NCT00055965 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine

Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Carboplatin
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 30, 2009