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
Recruitment status was Active, not recruiting
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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. 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: cisplatin Drug: ifosfamide Drug: mitomycin C Drug: paclitaxel Drug: vinblastine sulfate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 Start Date: | January 1999 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United Kingdom | |
| Christie Hospital N.H.S. Trust | |
| Manchester, England, United Kingdom, M20 4BX | |
| Study Chair: | Nick Thatcher, PhD, FRCP | Christie Hospital NHS Foundation Trust |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004887 History of Changes |
| Other Study ID Numbers: | CDR0000067562, CHNT-PC/MIC, EU-99046 |
| Study First Received: | March 7, 2000 |
| Last Updated: | November 2, 2010 |
| 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 Mitomycins Mitomycin Isophosphamide mustard Cisplatin Ifosfamide |
Vinblastine Carboplatin Paclitaxel Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 23, 2013