Chemotherapy, Tirapazamine, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Tirapazamine may make the tumor cells more sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and tirapazamine may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining chemotherapy with tirapazamine and radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Drug: tirapazamine Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Study Chair: | Derick H. Lau, MD | University of California, Davis |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00033410 History of Changes |
| Other Study ID Numbers: | CDR0000069281, CCC-PHI-31, CHNMC-PHI-31, NCI-571 |
| Study First Received: | April 9, 2002 |
| Last Updated: | February 6, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
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 Tirapazamine Carboplatin |
Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013