Combination Chemotherapy Plus 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. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I/II Study Of Concurrent Chemotherapy And Escalating Doses Of Radiotherapy (RT) For Unresectable Non-Small Cell Lung Cancer (NSCLC) Using A New RT Paradigm |
- Maximum tolerated dose (MTD) as assessed by dose-limiting toxicity within 1 month after completion of study treatment (phase I) [ Designated as safety issue: Yes ]
- Survival at 2 years (phase II) [ Designated as safety issue: No ]
- Survival time, time to disease progression, and time to local progression as assessed by clinical measures based on H&P after completion of study treatment [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 90 |
| Study Start Date: | May 2002 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the maximum tolerated dose of radiotherapy in combination with carboplatin and paclitaxel in patients with unresectable non-small cell lung cancer.
- Determine the 2-year survival of patients treated with this regimen.
- Determine the progression-free local control rate in patients treated this regimen.
- Determine the tolerability of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of radiotherapy.
Patients undergo radiotherapy* once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks. Treatment continutes in the absence of disease progression or unacceptable toxicity.
NOTE: *No prophylactic nodal radiotherapy is administered
Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12 additional patients are treated at that dose level in the phase II portion of the study.
Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years.
Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 90 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 non-small cell lung cancer (NSCLC)
- Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons
- Measurable disease
- Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study
- No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions
- No more than small effusions seen on chest CT scan only
- No supraclavicular adenopathy
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
- Direct bilirubin no greater than 1.5 times ULN
- AST no greater than 3 times ULN
Renal:
- Creatinine clearance at least 40 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Pulmonary:
- FEV_1 at least 1 L or 35% of predicted
Other:
- No grade 2 or greater peripheral neuropathy
- No weight loss of 10% or more within the past 3 months
- No uncontrolled infection
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer
- No other severe underlying disease that would preclude study participation
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic:
- No prior biologic therapy for NSCLC
- No concurrent biologic therapy
- No concurrent prophylactic filgrastim (G-CSF)
Chemotherapy:
- No prior chemotherapy for NSCLC
- No other concurrent chemotherapy
Endocrine therapy:
- No prior endocrine therapy for NSCLC
Radiotherapy:
- No prior radiotherapy for NSCLC
Surgery:
- No prior surgery for NSCLC
Contacts and Locations
Show 51 Study Locations| Study Chair: | Steven E. Schild, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
| Responsible Party: | Charles L. Loprinzi, Mayo Clinic Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00032032 History of Changes |
| Other Study ID Numbers: | CDR0000069250, NCCTG-N0028 |
| Study First Received: | March 8, 2002 |
| Last Updated: | February 19, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer |
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 |
Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013