Chemotherapy, Radiation Therapy, and Surgery in Treating Patients With Stage IIIA Non-small Cell Lung Cancer
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Purpose
Phase I trial to study the effectiveness of combining carboplatin and paclitaxel, radiation therapy with gadolinium texaphyrin, and surgery in treating patients who have stage IIIA non-small cell lung cancer. 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. Drugs such as gadolinium texaphyrin may make the tumor cells more sensitive to radiation therapy. Combining chemotherapy, radiation therapy, and surgery may kill more tumor cells
| Condition | Intervention | Phase |
|---|---|---|
|
Stage IIIA Non-small Cell Lung Cancer |
Drug: paclitaxel Drug: carboplatin Drug: motexafin gadolinium Procedure: conventional surgery Radiation: radiation therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Induction Carboplatin / Paclitaxel Chemotherapy, Pre-operative Radiotherapy With Gadolinium Texaphyrin (Gd-Tex), and Surgical Resection in Stage IIIA (N2) Non-small Cell Lung Carcinoma. |
- Maximum tolerated dose, defined as that dose at which fewer than one-third of patients experience dose-limiting toxicity (DLT) graded according to CTC version 2.0 [ Time Frame: Up to day 119 ] [ Designated as safety issue: Yes ]
- Concentrations of gadolinium in tumor, tumor involved lymph nodes, normal lung, and blood [ Time Frame: Up to day 123 ] [ Designated as safety issue: No ]
- Image pixel intensities in tumor, tumor involved lymph nodes, normal lung, and blood obtained by 1.5 Tesla MRI [ Time Frame: Up to day 119 ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | January 2000 |
| Primary Completion Date: | December 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours every 3 weeks for 3 courses. Three weeks after completion of induction chemotherapy, patients receive Gd-Tex IV over 30 minutes twice weekly for 10 doses during preoperative radiotherapy. Radiotherapy is administered daily 5 days a week for 5 weeks. Approximately 3.5 weeks after completion of preoperative radiotherapy, patients undergo complete surgical resection. Three hours prior to surgery, patients receive an eleventh dose of Gd-Tex if they do not develop grade 3 or 4 toxicity with the tenth dose. Patients also receive a MRI without contrast prior to surgery. If the tumor is found to be unresectable, patients may receive additional radiation and/or chemotherapy.
|
Drug: paclitaxel
Given IV
Other Names:
Drug: carboplatin
Given IV
Other Names:
Drug: motexafin gadolinium
Given IV
Other Names:
Procedure: conventional surgery
Undergo complete surgical resection
Other Name: surgery, conventional
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
|
Detailed Description:
OBJECTIVES:
I. Determine and compare the frequency and grade of toxicities with the use of gadolinium texaphyrin as a radiosensitizer at two dose levels during preoperative radiotherapy in patients with stage IIIA non-small cell lung cancer.
II. Measure the tumor, involved lymph nodes, and normal lung concentrations of gadolinium and compare to the image pixel intensity obtained by the 1.5 Tesla MRI in this patient population given this regimen.
OUTLINE: This is a dose escalation study of gadolinium texaphyrin (Gd-Tex).
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours every 3 weeks for 3 courses. Three weeks after completion of induction chemotherapy, patients receive Gd-Tex IV over 30 minutes twice weekly for 10 doses during preoperative radiotherapy. Radiotherapy is administered daily 5 days a week for 5 weeks. Approximately 3.5 weeks after completion of preoperative radiotherapy, patients undergo complete surgical resection. Three hours prior to surgery, patients receive an eleventh dose of Gd-Tex if they do not develop grade 3 or 4 toxicity with the tenth dose. Patients also receive a MRI without contrast prior to surgery. If the tumor is found to be unresectable, patients may receive additional radiation and/or chemotherapy.
Cohorts of 3-6 patients receive escalating doses of Gd-Tex 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 toxicities.
Patients are followed at 1 month and then every 4 months for 5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically confirmed non-small cell carcinoma of the lung
Surgical staging with mediastinoscopy or anterior thoracotomy required
- T1-T3, N2, M0
- Must appear resectable
- Performance status - Karnofsky 70-100%
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin normal
- AST no greater than 2.5 times upper limit of normal
- Creatinine no greater than 2 mg/dL
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- FEV greater than 0.8 L
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight loss no greater than 10% of total body weight within past 3 months
- No evidence of neuropathy
- No history of allergy to platinum compounds, paclitaxel, porphyrins, or antiemetics appropriate for administration in conjunction with protocol chemotherapy
- No concurrent uncontrolled illness (e.g., active infection)
- No medical contraindication to MRI (e.g., pacemaker or aneurysm clip)
- No G6PD deficiency
- No known history of porphyria
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered
- No prior chest radiotherapy in area of tumor/nodes
- No other concurrent investigational agents
Contacts and Locations| United States, Ohio | |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | John Grecula | Ohio State University Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005065 History of Changes |
| Other Study ID Numbers: | NCI-2012-01401, OSU 0003, U01CA076576, CDR0000067669 |
| Study First Received: | April 6, 2000 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
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 Motexafin gadolinium Carboplatin Paclitaxel |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic Photosensitizing Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Dermatologic Agents |
ClinicalTrials.gov processed this record on May 23, 2013