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Randomized Phase III Trial Of Carboplatin And Paclitaxel Plus Tirapazamine Versus Carboplatin And Paclitaxel In Patients With Advanced Non-Small Cell Lung Cancer

Phase 3
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Randomized Phase III Trial Of Carboplatin And Paclitaxel Plus Tirapazamine Versus Carboplatin And Paclitaxel In Patients With Advanced Non-Small Cell Lung Cancer


- Compare the effects of paclitaxel and carboplatin with or without tirapazamine on
progression-free survival and overall survival in patients with stage IV and selected
stage IIIB non-small cell lung cancer.

- Compare response rates in patients treated with these regimens.

- Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to weight loss (less
than 5% vs 5% or more), stage of disease (IIIB vs IV), and lactate dehydrogenase level
(normal vs abnormal). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive tirapazamine IV over 2 hours followed by paclitaxel IV over 3
hours and carboplatin IV over 30 minutes on day 1.

- Arm II: Patients receive paclitaxel and carboplatin as in arm I. Treatment continues
every 21 days for a total of 6 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed every 3 months for one year, and then every 6 months for 2 years, or
until death.

PROJECTED ACCRUAL: Approximately 500 patients (250 per arm) will be accrued for this study
within 20 months.

Inclusion Criteria


- Histologically or cytologically proven newly diagnosed advanced primary non-small
cell lung cancer (NSCLC), including the following cellular types:

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Unspecified carcinoma OR

- Recurrent disease after prior surgery and/or radiotherapy

- Stage IIIB disease

- T4 lesion due to malignant pleural effusion OR

- Stage IV disease

- Any T, any N, M1 (distant metastasis, including lesions in multiple lobes of the
ipsilateral lung)

- Measurable or evaluable disease

- Pleural effusions, ascites, and laboratory parameters not considered as only
evidence of disease

- Must be outside prior radiated field or area of prior surgical resection or new
lesion must be present

- No known brain metastases



- 18 and over

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified


- Absolute granulocyte count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9 g/dL


- Bilirubin no greater than 2 times upper limit of normal (ULN)

- SGOT or SGPT no greater than 2 times ULN

- Alkaline phosphatase no greater than 2 times ULN


- Creatinine no greater than ULN

- Creatinine clearance at least 50 mL/min


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No peripheral neuropathy (motor or sensory) of grade 2 or greater

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, carcinoma in situ of the cervix, or stage I/II cancer in
complete remission


Biologic therapy:

- No prior biologic therapy for NSCLC


- No prior systemic chemotherapy for NSCLC

Endocrine therapy:

- Not specified


- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy


- See Disease Characteristics

- At least 2 weeks since prior thoracic or other major surgery and recovered

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Stephen K. Williamson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Kansas


United States: Federal Government

Study ID:




Start Date:

November 2000

Completion Date:

April 2006

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



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