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A Phase I Study Of Tirapazamine (NSC 130181) Paclitaxel And Carboplatin With Concurrent Radiation Followed By Tirapazamine/Paclitaxel/Carboplatin Consolidation For Stage III Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase I Study Of Tirapazamine (NSC 130181) Paclitaxel And Carboplatin With Concurrent Radiation Followed By Tirapazamine/Paclitaxel/Carboplatin Consolidation For Stage III Non-Small Cell Lung Cancer


OBJECTIVES:

- Determine the maximum tolerated dose of tirapazamine when administered with paclitaxel,
carboplatin, and concurrent radiotherapy in patients with stage IIB-IIIB non-small cell
lung cancer.

- Determine, preliminarily, the response rate and survival of patients treated with this
regimen.

- Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter, dose-escalation study of tirapazamine.

Patients receive induction chemotherapy comprising tirapazamine IV over 2 hours and
carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and paclitaxel IV over 1
hour on days 1, 4, 8, 11, 15, 18, 22, 25, 29, 32, 36, and 39. Beginning on day 1, patients
undergo radiotherapy once daily 5 days a week for 6.5 weeks. Beginning 4-5 weeks after
completion of radiotherapy, patients with stable or responding disease receive consolidation
chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on
days 1 and 22.

Cohorts of 3-6 patients receive escalating doses of tirapazamine until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed primary bronchogenic non-small cell lung
cancer

- Adenocarcinoma

- Large cell carcinoma

- Squamous cell carcinoma

- Stage IIIA or IIIB disease (T1-4, N2-3)

- Mediastinal lymph nodes at least 2 cm in diameter by radiography sufficient to
stage N2-3 (must be node positive [cytologically or histologically confirmed] if
largest mediastinal node is less than 2 cm in diameter) OR

- Selected stage IIB disease (T3, N0 or T3, N1 with a medical condition that precludes
surgery)

- No malignant pleural effusion

- Measurable or evaluable disease by chest x-ray or CT scan

- No metastatic disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-2 OR

- ECOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,500/mm^3

- Platelet count normal

Hepatic:

- Not specified

Renal:

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- No uncontrolled congestive heart failure

- No unstable angina

- No unstable cardiac arrhythmias

Pulmonary:

- FEV_1 at least 1.0 L

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No clinically significant hearing loss

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for lung cancer

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy for lung cancer

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Derick H. Lau, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

CDR0000069281

NCT ID:

NCT00033410

Start Date:

March 2002

Completion Date:

Related Keywords:

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

Name

Location

University of California Davis Cancer CenterSacramento, California  95817
City of Hope Comprehensive Cancer CenterDuarte, California  91010