Phase I trial of outpatient weekly docetaxel, carboplatin and concurrent thoracic radiation therapy for stage III unresectable non-small-cell lung cancer

A Vanderbilt cancer center affiliate network (VCCAN) trial

H. Choy, R. F. DeVore, K. R. Hande, L. L. Porter, P. A. Rosenblatt, B. Slovis, K. Laporte, Y. Shyr, D. H. Johnson

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Purpose: Docetaxel, an active agent for non-small cell lung cancer (NSCLC), has demonstrated activity as a radiosensitizer in numerous pre-clinical studies. We conducted a phase I trial to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of weekly Docetaxel, Carboplatin with concurrent thoracic radiation therapy (TRT) in patients with unresectable stage III NSCLC. Patients and methods: In this phase I clinical trial, Docetaxel was administered weekly as a 1-h intravenous infusion for 6 weeks with a starting dose of 20 mg/m2. Docetaxel doses were escalated by 10 mg/m2 increments in successive cohorts of three patients. DLT was defined as grade ≥3 nonhematologic and hematologic toxicity according to RTOG toxicity criteria. Once the DLT of Docetaxel alone was reached, weekly Carboplatin (AUC 2) was added at a DLT-2 dose of Docetaxel (two dose levels below that of dose limiting toxicity). Docetaxel doses were again escalated at 10 mg/m2 increments in successive cohorts of three new patients to define further DLT and MTD of Docetaxel/Carboplatin with TRT. TRT was administered to the primary tumor and regional lymph nodes (40 Gy) followed by a boost to the tumor (20 Gy). Results: Fifteen patients were entered onto this study with Docetaxel alone through three dose escalations (from 20 to 40 mg/m2 weekly). The DLT of weekly Docetaxel/TRT was esophagitis and the MTD was 30 mg/m2 per week for 6 weeks. Nine more patients were added with the Docetaxel/Carboplatin/TRT regimen. The DLT of weekly Docetaxel/Carboplatin with TRT was esophagitis and the MTD of Docetaxel was 20 mg/m2 per week with weekly Carboplatin (AUC 2). There were 2 complete responses and 13 partial responses in 25 evaluable patients (RR 60%). Conclusions: This combination regimen has activity with manageable toxicity in patients with stage III NSCLC. A phase II study is planned to define activity.

Original languageEnglish (US)
JournalLung Cancer
Volume34
Issue number3
StatePublished - 2001

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docetaxel
Carboplatin
Non-Small Cell Lung Carcinoma
Outpatients
Radiotherapy
Thorax
Neoplasms
Maximum Tolerated Dose
Esophagitis
Area Under Curve

Keywords

  • Carboplatin
  • Docetaxel
  • Non-small cell lung cancer
  • Thoracic radiation therapy

ASJC Scopus subject areas

  • Oncology

Cite this

Phase I trial of outpatient weekly docetaxel, carboplatin and concurrent thoracic radiation therapy for stage III unresectable non-small-cell lung cancer : A Vanderbilt cancer center affiliate network (VCCAN) trial. / Choy, H.; DeVore, R. F.; Hande, K. R.; Porter, L. L.; Rosenblatt, P. A.; Slovis, B.; Laporte, K.; Shyr, Y.; Johnson, D. H.

In: Lung Cancer, Vol. 34, No. 3, 2001.

Research output: Contribution to journalArticle

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title = "Phase I trial of outpatient weekly docetaxel, carboplatin and concurrent thoracic radiation therapy for stage III unresectable non-small-cell lung cancer: A Vanderbilt cancer center affiliate network (VCCAN) trial",
abstract = "Purpose: Docetaxel, an active agent for non-small cell lung cancer (NSCLC), has demonstrated activity as a radiosensitizer in numerous pre-clinical studies. We conducted a phase I trial to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of weekly Docetaxel, Carboplatin with concurrent thoracic radiation therapy (TRT) in patients with unresectable stage III NSCLC. Patients and methods: In this phase I clinical trial, Docetaxel was administered weekly as a 1-h intravenous infusion for 6 weeks with a starting dose of 20 mg/m2. Docetaxel doses were escalated by 10 mg/m2 increments in successive cohorts of three patients. DLT was defined as grade ≥3 nonhematologic and hematologic toxicity according to RTOG toxicity criteria. Once the DLT of Docetaxel alone was reached, weekly Carboplatin (AUC 2) was added at a DLT-2 dose of Docetaxel (two dose levels below that of dose limiting toxicity). Docetaxel doses were again escalated at 10 mg/m2 increments in successive cohorts of three new patients to define further DLT and MTD of Docetaxel/Carboplatin with TRT. TRT was administered to the primary tumor and regional lymph nodes (40 Gy) followed by a boost to the tumor (20 Gy). Results: Fifteen patients were entered onto this study with Docetaxel alone through three dose escalations (from 20 to 40 mg/m2 weekly). The DLT of weekly Docetaxel/TRT was esophagitis and the MTD was 30 mg/m2 per week for 6 weeks. Nine more patients were added with the Docetaxel/Carboplatin/TRT regimen. The DLT of weekly Docetaxel/Carboplatin with TRT was esophagitis and the MTD of Docetaxel was 20 mg/m2 per week with weekly Carboplatin (AUC 2). There were 2 complete responses and 13 partial responses in 25 evaluable patients (RR 60{\%}). Conclusions: This combination regimen has activity with manageable toxicity in patients with stage III NSCLC. A phase II study is planned to define activity.",
keywords = "Carboplatin, Docetaxel, Non-small cell lung cancer, Thoracic radiation therapy",
author = "H. Choy and DeVore, {R. F.} and Hande, {K. R.} and Porter, {L. L.} and Rosenblatt, {P. A.} and B. Slovis and K. Laporte and Y. Shyr and Johnson, {D. H.}",
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T1 - Phase I trial of outpatient weekly docetaxel, carboplatin and concurrent thoracic radiation therapy for stage III unresectable non-small-cell lung cancer

T2 - A Vanderbilt cancer center affiliate network (VCCAN) trial

AU - Choy, H.

AU - DeVore, R. F.

AU - Hande, K. R.

AU - Porter, L. L.

AU - Rosenblatt, P. A.

AU - Slovis, B.

AU - Laporte, K.

AU - Shyr, Y.

AU - Johnson, D. H.

PY - 2001

Y1 - 2001

N2 - Purpose: Docetaxel, an active agent for non-small cell lung cancer (NSCLC), has demonstrated activity as a radiosensitizer in numerous pre-clinical studies. We conducted a phase I trial to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of weekly Docetaxel, Carboplatin with concurrent thoracic radiation therapy (TRT) in patients with unresectable stage III NSCLC. Patients and methods: In this phase I clinical trial, Docetaxel was administered weekly as a 1-h intravenous infusion for 6 weeks with a starting dose of 20 mg/m2. Docetaxel doses were escalated by 10 mg/m2 increments in successive cohorts of three patients. DLT was defined as grade ≥3 nonhematologic and hematologic toxicity according to RTOG toxicity criteria. Once the DLT of Docetaxel alone was reached, weekly Carboplatin (AUC 2) was added at a DLT-2 dose of Docetaxel (two dose levels below that of dose limiting toxicity). Docetaxel doses were again escalated at 10 mg/m2 increments in successive cohorts of three new patients to define further DLT and MTD of Docetaxel/Carboplatin with TRT. TRT was administered to the primary tumor and regional lymph nodes (40 Gy) followed by a boost to the tumor (20 Gy). Results: Fifteen patients were entered onto this study with Docetaxel alone through three dose escalations (from 20 to 40 mg/m2 weekly). The DLT of weekly Docetaxel/TRT was esophagitis and the MTD was 30 mg/m2 per week for 6 weeks. Nine more patients were added with the Docetaxel/Carboplatin/TRT regimen. The DLT of weekly Docetaxel/Carboplatin with TRT was esophagitis and the MTD of Docetaxel was 20 mg/m2 per week with weekly Carboplatin (AUC 2). There were 2 complete responses and 13 partial responses in 25 evaluable patients (RR 60%). Conclusions: This combination regimen has activity with manageable toxicity in patients with stage III NSCLC. A phase II study is planned to define activity.

AB - Purpose: Docetaxel, an active agent for non-small cell lung cancer (NSCLC), has demonstrated activity as a radiosensitizer in numerous pre-clinical studies. We conducted a phase I trial to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of weekly Docetaxel, Carboplatin with concurrent thoracic radiation therapy (TRT) in patients with unresectable stage III NSCLC. Patients and methods: In this phase I clinical trial, Docetaxel was administered weekly as a 1-h intravenous infusion for 6 weeks with a starting dose of 20 mg/m2. Docetaxel doses were escalated by 10 mg/m2 increments in successive cohorts of three patients. DLT was defined as grade ≥3 nonhematologic and hematologic toxicity according to RTOG toxicity criteria. Once the DLT of Docetaxel alone was reached, weekly Carboplatin (AUC 2) was added at a DLT-2 dose of Docetaxel (two dose levels below that of dose limiting toxicity). Docetaxel doses were again escalated at 10 mg/m2 increments in successive cohorts of three new patients to define further DLT and MTD of Docetaxel/Carboplatin with TRT. TRT was administered to the primary tumor and regional lymph nodes (40 Gy) followed by a boost to the tumor (20 Gy). Results: Fifteen patients were entered onto this study with Docetaxel alone through three dose escalations (from 20 to 40 mg/m2 weekly). The DLT of weekly Docetaxel/TRT was esophagitis and the MTD was 30 mg/m2 per week for 6 weeks. Nine more patients were added with the Docetaxel/Carboplatin/TRT regimen. The DLT of weekly Docetaxel/Carboplatin with TRT was esophagitis and the MTD of Docetaxel was 20 mg/m2 per week with weekly Carboplatin (AUC 2). There were 2 complete responses and 13 partial responses in 25 evaluable patients (RR 60%). Conclusions: This combination regimen has activity with manageable toxicity in patients with stage III NSCLC. A phase II study is planned to define activity.

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KW - Thoracic radiation therapy

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