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| ID | Type | Description | Link |
|---|---|---|---|
| RTOG-L-0017 | |||
| CDR0000068622 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine, carboplatin, and paclitaxel, work in 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 radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of combining combination chemotherapy with radiation therapy in treating patients who have stage IIIA or stage IIIB non-small cell lung cancer.
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of gemcitabine and paclitaxel. Patients are sequentially assigned to 1 of 3 treatment regimens.
At 3 weeks after completion of chemoradiotherapy, all patients receive adjuvant gemcitabine IV over 30-60 minutes on days 71, 78, 92, and 99 and carboplatin IV over 30 minutes on days 71 and 92.
The first 6 patients enrolled receive regimen A to determine the safety of the initial dose of gemcitabine. After completion of regimen A, cohorts of 3-6 patients receive escalating doses of gemcitabine in regimen B (closed to accrual as of 5/13/03) until the maximum tolerated dose (MTD) is determined. In a separate sequence, cohorts of 3-6 patients receive alternating escalating doses of gemcitabine and paclitaxel in regimen C until the MTD is determined. The MTD is defined as the dose preceding that at which at least 3 of 6 patients experience dose-limiting toxicity.
Patients are followed at 3 months, 6 months, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 78 patients will be accrued for this study within 29 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Sequence A: Gemcitabine 300 mg/m2/week plus radiation therapy (RT) |
|
| Arm 2 | Experimental | Sequence B: Gemcitabine 300 mg/m2/week plus paclitaxel 30 mg/m2/week and RT |
|
| Arm 3 | Experimental | Sequence A: Gemcitabine 300 mg/m2/week plus carboplatin 2 AUC and RT |
|
| Arm 4 | Experimental | Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 30 mg/m2/week and RT |
|
| Arm 6 | Experimental | Sequence B: Gemcitabine 450 mg/m2/week plus paclitaxel 40 mg/m2/week and RT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin | Drug |
| ||
| gemcitabine hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the maximum tolerated dose of gemcitabine with carboplatin-based chemotherapy and radiation therapy | From start of treatment to 90 days | |
| To determine the maximum tolerated dose of gemcitabine with paclitaxel-based chemotherapy and radiation therapy | From start of treatment to 90 days |
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DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed loco-regionally advanced non-small cell lung cancer meeting one of the following staging criteria:
Measurable disease on three-dimensional planning CT scan
No post-resection intrathoracic tumor recurrence
No pleural effusion on chest x-ray except those occurring after attempted thoracotomy or other invasive thoracic procedure
No evidence of small cell histology
No evidence of hematogenous or distant metastases
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Hak Choy, MD | Simmons Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCOP - Bay Area Tumor Institute | Oakland | California | 94609-3305 | United States | ||
| University of Miami Sylvester Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19096311 | Result | Choy H, Jain AK, Moughan J, Curran W, Whipple G, Demas WF, Ettinger DS. RTOG 0017: a phase I trial of concurrent gemcitabine/carboplatin or gemcitabine/paclitaxel and radiation therapy ("ping-pong trial") followed by adjuvant chemotherapy for patients with favorable prognosis inoperable stage IIIA/B non-small cell lung cancer. J Thorac Oncol. 2009 Jan;4(1):80-6. doi: 10.1097/JTO.0b013e318191503f. | |
| Result | Choy H, Swann S, Curran W, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG 0017 study. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-70, S42, 2005. | ||
| Result | Choy H, Swann S, Walter C, et al.: A phase I trial of gemcitabine, carboplatin or gemcitabine, paclitaxel and concurrent radiation therapy followed by consolidative gemcitabine and carboplatin for inoperable stage III non-small cell lung cancer: an RTOG study. [Abstract] J Clin Oncol 23 (Suppl 16): A-7103, 646s, 2005. |
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| Arm 8 | Experimental | Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 40 mg/m2/week and RT |
|
| Arm 10 | Experimental | Sequence B: Gemcitabine 600 mg/m2/week plus paclitaxel 50 mg/m2/week and RT |
|
| Arm 12 | Experimental | Sequence B: Gemcitabine 750 mg/m2/week plus paclitaxel 50 mg/m2/week and RT |
|
| Arm 14 | Experimental | Sequence B: Gemcitabine 900 mg/m2/week plus paclitaxel 50 mg/m2/week and RT |
|
| Arm 5 | Experimental | Sequence A: Gemcitabine 450 mg/m2/week plus carboplatin 2 AUC and RT |
|
| Arm 7 | Experimental | Sequence A: Gemcitabine 600 mg/m2/week plus carboplatin 2 AUC and RT |
|
| Arm 9 | Experimental | Sequence A: Gemcitabine 750 mg/m2/week plus carboplatin 2 AUC and RT |
|
| Arm 11 | Experimental | Sequence A: Gemcitabine 900 mg/m2/week plus carboplatin 2 AUC and RT |
|
| Drug |
|
| paclitaxel | Drug |
|
| radiation therapy | Radiation |
|
| Miami |
| Florida |
| 33136 |
| United States |
| Wendt Regional Cancer Center of Finley Hospital | Dubuque | Iowa | 52001 | United States |
| Monmouth Medical Center | Long Branch | New Jersey | 07740-6395 | United States |
| Akron City Hospital | Akron | Ohio | 44304 | United States |
| Cancer Care Center, Incorporated | Salem | Ohio | 44460 | United States |
| Delaware County Memorial Hospital | Drexel Hill | Pennsylvania | 19026 | United States |
| Dale and Frances Hughes Cancer Center | East Stroudsburg | Pennsylvania | 18301 | United States |
| Mercy Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15219 | United States |
| Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center | Nashville | Tennessee | 37232-5671 | United States |
| Cottonwood Hospital Medical Center | Murray | Utah | 84107 | United States |
| McKay-Dee Hospital Center | Ogden | Utah | 84403 | United States |
| Utah Valley Regional Medical Center - Provo | Provo | Utah | 84604 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Dixie Regional Medical Center | St. George | Utah | 84770 | United States |
| Danville Regional Medical Center | Danville | Virginia | 24541 | United States |
| Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center | La Crosse | Wisconsin | 54601 | United States |
| Medical College of Wisconsin Cancer Center | Milwaukee | Wisconsin | 53226 | United States |
| Veterans Affairs Medical Center - Milwaukee (Zablocki) | Milwaukee | Wisconsin | 53295 | United States |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000093542 | Gemcitabine |
| D017239 | Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
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