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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
This study is ongoing, but not recruiting participants.
First Received: March 7, 2000   Last Updated: July 23, 2008   History of Changes
Sponsored by: Christie Hospital NHS Foundation Trust
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004887
  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
Phase III

MedlinePlus related topics: Cancer Lung Cancer Surgery
Drug Information available for: Mitomycin Cisplatin Paclitaxel Carboplatin Vinblastine sulfate Vinblastine Mitomycins Ifosfamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
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

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

Study Start Date: January 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004887

Locations
United Kingdom, England
Christie Hospital N.H.S. 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

Study ID Numbers: CDR0000067562, CHNT-PC/MIC, EU-99046
Study First Received: March 7, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004887     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

Study placed in the following topic categories:
Thoracic Neoplasms
Vinblastine
Antimitotic Agents
Carboplatin
Mitomycins
Carcinoma
Anti-Bacterial Agents
Ifosfamide
Radiation-Sensitizing Agents
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Paclitaxel
Mechlorethamine
Lung Diseases
Tubulin Modulators
Mitomycin
Non-small Cell Lung Cancer
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Alkylating Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Isophosphamide mustard

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Antibiotics, Antineoplastic
Mitomycins
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Mitomycin
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Mitosis Modulators
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms
Ifosfamide
Radiation-Sensitizing Agents
Paclitaxel
Lung Diseases
Tubulin Modulators
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on May 07, 2009