Clinical 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

This study is no longer recruiting patients.

Sponsored by: Christie Hospital N.H.S. Trust
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
stage IIIA non-small cell lung cancer
stage IV non-small cell lung cancer
stage IIIB non-small cell lung cancer
 Procedure: chemotherapy
 Drug: carboplatin
 Drug: cisplatin
 Drug: ifosfamide
 Drug: mitomycin
 Drug: paclitaxel
 Drug: vinblastine
Phase III

MedlinePlus related topics:  Lung Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of Paclitaxel and Carboplatin Versus Standard Platinum Therapy in Patients With Inoperable Advanced Non-Small Cell Lung Cancer

Further Study Details: 

Study start: January 1999

OBJECTIVES: I. 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. II. Compare the toxic effects of these two regimens in this patient population. III. Compare the performance status, tumor response, and quality of life in these patients after these treatment regimens.

PROTOCOL 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 above

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

Biologic therapy: Not specified

Chemotherapy: No prior chemotherapy

Endocrine therapy: Not specified

Radiotherapy:

Surgery: See Disease Characteristics

--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/mm3
  • Platelet count at least 100,000/mm3

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

Location Information


United Kingdom, England
      Christie Hospital N.H.S. Trust, Manchester,  England,  M20 4BX,  United Kingdom

Study chairs or principal investigators

Nick Thatcher,  Study Chair,  Christie Hospital N.H.S. Trust   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067562; CHNT-PC/MIC; EU-99046
Record last reviewed:  July 2003
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004887
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005