NCT00006484

Combination Chemotherapy With or Without Tirapazamine in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00006484

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin plus paclitaxel with or without tirapazamine in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Eligibility

DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Zubrod 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 9 g/dL

Hepatic:

* 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

Renal:

* Creatinine no greater than ULN
* Creatinine clearance at least 50 mL/min

Other:

* 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior biologic therapy for NSCLC

Chemotherapy:

* No prior systemic chemotherapy for NSCLC

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy

Surgery:

* See Disease Characteristics
* At least 2 weeks since prior thoracic or other major surgery and recovered

Disease(s) and\or Condition(s)

Lung Cancer

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: carboplatin
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: paclitaxel
- Description:
- Arm Group Labels:
- Type: DRUG
- Name: tirapazamine
- Description:
- Arm Group Labels:

Sponsor

SWOG Cancer Research Network