Hospitalization Rates of Patients With Non-Small Cell Lung Cancer Treated With Gemcitabine and Either Cisplatin or Carboplatin
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Christie Hospital NHS Foundation Trust
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00055965
First received: March 6, 2003
Last updated: January 24, 2009
Last verified: January 2009
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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:
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) |
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 | |
| 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:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00055965 History of Changes |
| Other Study ID Numbers: | CDR0000271903, CHNT-GEM-HOSP, EU-20245 |
| Study First Received: | March 6, 2003 |
| Last Updated: | January 24, 2009 |
| 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:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Gemcitabine Cisplatin Carboplatin |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on May 22, 2013