Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer
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Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.
| 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: | A Phase I/II Dose Intensification Study Using Three Dimensional Conformal Radiation Therapy And Concurrent Chemotherapy For Patients With Inoperable, Non-Small Cell Lung Cancer |
- Maximum tolerated dose [ Designated as safety issue: Yes ]
- Percentage of patients who survive at least 12 months [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Partial organ tolerance doses for lung and esophagus [ Designated as safety issue: Yes ]
- Complete response rate at 3 months after therapy [ Designated as safety issue: No ]
| Estimated Enrollment: | 73 |
| Study Start Date: | July 2001 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of 01/13/04.)
- Determine the 12-month survival rate in patients treated with this regimen. (Phase II) (Closed to accrual as of 11/27/07.)
- Determine the toxicity of this regimen in these patients.
- Determine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen.
- Determine the complete response rate in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal radiotherapy.
- Phase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 7-8 weeks. Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.
Cohorts of 7-9 patients receive escalating doses of 3-dimensional conformal radiotherapy until the maximum tolerated dose (MTD) is determined when given in combination with chemotherapy. The MTD is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity.
- Phase II: Additional patients are accrued and treated as above at the MTD. At least 3 weeks after completing radiotherapy, patients may receive additional chemotherapy comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once. Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3-5 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 73 patients (27 for phase I [closed to accrual as of 10/28/04] and 46 for phase II) will be accrued for this study within 1-1.5 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable stage IIIA or IIIB non-small cell lung cancer
- Squamous cell carcinoma
- Adenocarcinoma
- Large cell carcinoma
- Non-small cell carcinoma not otherwise specified
- All detectable primary tumor and involved regional lymph nodes must be encompassed by radiotherapy fields
- Measurable disease on 3-dimensional planning CT scan
- No undifferentiated small cell (oat cell or high-grade neuroendocrine) carcinoma
- No stage IV or recurrent disease
- No distant metastases or supraclavicular lymph node involvement
- No significant atelectasis (i.e., atelectasis of an entire lung)
- No pleural effusions, pericardial effusions, or superior vena cava syndrome
- No lung cancer within the past 2 years
- Ineligible for currently open RTOG phase III lung protocols
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Zubrod 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- AST less than 2 times upper limit of normal
Renal:
- Creatinine no greater than 2.0 mg/dL
Pulmonary:
- FEV_1 at least 1.0 L
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No weight loss greater than 5% in the past 6 months
- No other malignancy within the past year except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior biologic response modifiers for current lung cancer
- At least 5 years since prior biologic response modifiers
Chemotherapy:
- No prior chemotherapy for current lung cancer
- At least 5 years since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to the thorax
Surgery:
- No prior complete tumor resection
Contacts and Locations
Show 41 Study Locations| Study Chair: | Jeffrey Bradley, MD | Mallinckrodt Institute of Radiology at Washington University Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Walter John Curran, Jr, Radiation Therapy Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00023673 History of Changes |
| Other Study ID Numbers: | CDR0000068850, RTOG-L-0117 |
| Study First Received: | September 13, 2001 |
| Last Updated: | May 14, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 adenosquamous 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 23, 2013