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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2000 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00004887
First received: March 7, 2000
Last updated: September 19, 2013
Last verified: March 2000
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004887

Locations
United Kingdom
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

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: September 19, 2013
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
Paclitaxel
Vinblastine
Isophosphamide mustard
Cisplatin
Carboplatin
Ifosfamide
Mitomycins
Mitomycin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on October 16, 2014