Combination Chemotherapy, Surgery, 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. Giving combination chemotherapy with radiation therapy before and after surgery may shrink the tumor so it can be removed during surgery and may kill any remaining tumor cells following surgery.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel and carboplatin with radiation therapy and surgery in treating patients who have newly diagnosed locally advanced non-small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: carboplatin Drug: paclitaxel Procedure: conventional surgery Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Trimodality Protocol for the Treatment of Locally Advanced, Potentially Resectable Non-Small Cell Lung Cancer Targeting |
- Maximum tolerated dose [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 57 |
| Study Start Date: | July 2002 |
OBJECTIVES:
- Determine the complete resection rate and toxic death rate of patients with locally advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.
- Determine the survival, event-free survival, and incidence of pathologic complete remission of patients treated with this regimen.
- Determine the protocol completion rate (CR) of patients treated with this regimen.
- Determine the feasibility and toxicity of this regimen in these patients.
- Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom from distant metastasis rate, and freedom from local regional failure rate of patients treated with this regimen.
OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6 weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36.
Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients with resectable disease undergo surgical resection within 4-8 weeks after induction therapy. Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.
Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant treatment repeats every 4 weeks for 3 courses.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed, newly diagnosed, unilateral primary non-small cell lung cancer (NSCLC)
- Must have involvement of the superior sulcus, chest wall, or mediastinum
Must have at least 1 of the following:
- Locally advanced Pancoast tumors with no documented mediastinal or supraclavicular nodal involvement (T3-T4, N0-1)
- Resectable chest wall disease (T3, N0-1)
- Marginally resectable T4, N0-1, or NX central NSCLC
- N2 patients who are potentially resectable after induction chemoradiotherapy
- No evidence of extrathoracic spread to liver, adrenals, brain, or bone
- No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or distant metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- SGOT no greater than 3 times upper limit of normal
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No superior vena cava syndrome
- No myocardial infarction within the past 6 months
- No active uncontrolled congestive heart failure
- No active uncontrolled arrhythmia within the past 6 months
Pulmonary
- FEV1 at least 800 mL
Other
- No other active invasive malignancy requiring therapy within the past 2 years
- No ongoing need for adjuvant therapy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 3 months after study entry
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior pelvic or thoracic radiotherapy
Surgery
- See Disease Characteristics
Other
- Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed provided cardiac conditions are stable
Contacts and Locations| United States, Pennsylvania | |
| Fox Chase Cancer Center - Philadelphia | |
| Philadelphia, Pennsylvania, United States, 19111-2497 | |
| Principal Investigator: | Aruna J. Turaka, MD | Fox Chase Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00043108 History of Changes |
| Other Study ID Numbers: | CDR0000256334, P30CA006927, FCCC-02014, NCI-G02-2097 |
| Study First Received: | August 5, 2002 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Fox Chase Cancer Center:
|
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 19, 2013