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Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
carboplatin
cisplatin
ifosfamide
mitomycin C
paclitaxel
vinblastine sulfate
Sponsored by
The Christie NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed inoperable advanced non-small cell lung cancer Stage IIIA, IIIB, or IV Not eligible for curative radiotherapy or surgery Measurable or evaluable disease No bony lesions as only site of measurable disease No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 (ECOG 3 allowed in some cases) Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (no greater than 5 times ULN for liver metastases) Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Other: Not pregnant Fertile patients must use effective contraception during and for 3 months after study No active infection No other serious systemic disorder that would preclude compliance No second malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer No peripheral neuropathy, significant neurological disorders (e.g., seizures), or psychiatric disorders PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy allowed if measurable disease outside of irradiated field Surgery: See Disease Characteristics

Sites / Locations

  • Christie Hospital N.H.S. Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
September 19, 2013
Sponsor
The Christie NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00004887
Brief Title
Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery
Official Title
A Randomized Phase III Comparative Study of Paclitaxel With Carboplatin Versus Mitomycin, Ifosfamide, Cisplatin (MIC) Chemotherapy in Inoperable Advanced Stage Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2000
Overall Recruitment Status
Unknown status
Study Start Date
January 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The Christie NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether paclitaxel and carboplatin is more effective than standard chemotherapy for advanced non-small cell lung cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel and carboplatin chemotherapy with that of standard chemotherapy in treating patients who have stage III or stage IV non-small cell lung cancer that cannot be removed during surgery.
Detailed Description
OBJECTIVES: Compare the one and two year survival of patients with inoperable advanced non-small cell lung cancer treated with paclitaxel and cisplatin versus standard platinum therapy. Compare the toxic effects of these two regimens in this patient population. Compare the performance status, tumor response, and quality of life in these patients after these treatment regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center, stage of disease (IIIA vs IIIB vs IV), or performance status (ECOG O vs 1 vs 2 vs 3). Patients are randomized to one of two treatment arms: Arm I: Patients receive paclitaxel IV over 3 hours, followed by carboplatin IV over 30 minutes on day 1. Arm II: Patients receive mitomycin IV, ifosfamide IV over 3 hours, and cisplatin IV over 1 hour on day 1 OR mitomycin IV, vinblastine IV, and cisplatin IV over 4 hours on day 1. Treatment continues every 3 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before each treatment course. Patients are followed for survival. PROJECTED ACCRUAL: Approximately 300 patients (150 per treatment arm) will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Intervention Type
Drug
Intervention Name(s)
mitomycin C
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed inoperable advanced non-small cell lung cancer Stage IIIA, IIIB, or IV Not eligible for curative radiotherapy or surgery Measurable or evaluable disease No bony lesions as only site of measurable disease No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 (ECOG 3 allowed in some cases) Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) AST or ALT no greater than 3 times ULN (no greater than 5 times ULN for liver metastases) Renal: Creatinine normal OR Creatinine clearance at least 60 mL/min Other: Not pregnant Fertile patients must use effective contraception during and for 3 months after study No active infection No other serious systemic disorder that would preclude compliance No second malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer No peripheral neuropathy, significant neurological disorders (e.g., seizures), or psychiatric disorders PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Prior radiotherapy allowed if measurable disease outside of irradiated field Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Thatcher, PhD, FRCP
Organizational Affiliation
The Christie NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Christie Hospital N.H.S. Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Paclitaxel and Carboplatin Chemotherapy Compared With Standard Chemotherapy in Treating Patients With Stage III or Stage IV Non-small Cell Lung Cancer That Cannot Be Removed During Surgery

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