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

Hak Choy, Anshu K. Jain, Jennifer Moughan, Walter Curran, Gary Whipple, William F. Demas, David S Ettinger

Research output: Contribution to journalArticle

Abstract

PURPOSE: The optimal dose of gemcitabine that can be used with concurrent radiation therapy for locally advanced non-small cell lung cancer has not been well defined. This trial addresses this question in an alternating sequence "ping-pong" design trial to find the maximum tolerated dose (MTD) for gemcitabine/carboplatin (Sequence A) or gemcitabine/paclitaxel (Sequence B) and thoracic radiation therapy followed by adjuvant gemcitabine/carboplatin chemotherapy. PATIENTS AND METHODS: Thirty-five patients with histologically confirmed Stage IIIA/B non-small cell lung cancer were entered into two separate sequences, each with multiple cohorts. A dose level was considered acceptable if, of the first six eligible patients on each cohort, fewer than three experienced dose limiting toxicities. RESULTS: Sequence B of this 2 sequence "ping-pong" trial closed early due to toxicity in cohort 2 (gemcitabine 300 mg/m/wk and paclitaxel 30 mg/m/wk). On Sequence A, the MTD was the cohort 5 dose: gemcitabine 450 mg/m/wk and carboplatin 2 area under curve (AUC) concurrently with thoracic radiation. Cohort 7 (gemcitabine 600 mg/m/wk and carboplatin 2 AUC) showed 4 dose limiting toxicities: 2 grade 3 esophagitis; one grade 3 febrile neutropenia; and one grade 4 neutropenia. CONCLUSION: Concurrent gemcitabine/paclitaxel chemoradiation regimen followed by adjuvant gemcitabine/carboplatin produced excessive toxicity at the lowest tested dose combination and was not suitable for further study in this trial. Meanwhile, the MTD of concurrent gemcitabine/carboplatin chemoradiation was determined to be gemcitabine 450 mg/m and carboplatin AUC-2. This combination was found to be tolerable. Although not a primary end point, survival results are summarized as well.

Original languageEnglish (US)
Pages (from-to)80-86
Number of pages7
JournalJournal of Thoracic Oncology
Volume4
Issue number1
DOIs
StatePublished - Jan 2009

Fingerprint

gemcitabine
Carboplatin
Adjuvant Chemotherapy
Paclitaxel
Non-Small Cell Lung Carcinoma
Radiotherapy
Maximum Tolerated Dose
Area Under Curve
Thorax
Febrile Neutropenia
Esophagitis

Keywords

  • Carboplatin
  • Chemoradiation
  • Concurrent chemoradiation
  • Gemcitabine
  • Non small cell lung cancer
  • NSCLC
  • Paclitaxel

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Medicine(all)

Cite this

@article{7466d3c5b13345e89b6b951428f9ade8,
title = "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",
abstract = "PURPOSE: The optimal dose of gemcitabine that can be used with concurrent radiation therapy for locally advanced non-small cell lung cancer has not been well defined. This trial addresses this question in an alternating sequence {"}ping-pong{"} design trial to find the maximum tolerated dose (MTD) for gemcitabine/carboplatin (Sequence A) or gemcitabine/paclitaxel (Sequence B) and thoracic radiation therapy followed by adjuvant gemcitabine/carboplatin chemotherapy. PATIENTS AND METHODS: Thirty-five patients with histologically confirmed Stage IIIA/B non-small cell lung cancer were entered into two separate sequences, each with multiple cohorts. A dose level was considered acceptable if, of the first six eligible patients on each cohort, fewer than three experienced dose limiting toxicities. RESULTS: Sequence B of this 2 sequence {"}ping-pong{"} trial closed early due to toxicity in cohort 2 (gemcitabine 300 mg/m/wk and paclitaxel 30 mg/m/wk). On Sequence A, the MTD was the cohort 5 dose: gemcitabine 450 mg/m/wk and carboplatin 2 area under curve (AUC) concurrently with thoracic radiation. Cohort 7 (gemcitabine 600 mg/m/wk and carboplatin 2 AUC) showed 4 dose limiting toxicities: 2 grade 3 esophagitis; one grade 3 febrile neutropenia; and one grade 4 neutropenia. CONCLUSION: Concurrent gemcitabine/paclitaxel chemoradiation regimen followed by adjuvant gemcitabine/carboplatin produced excessive toxicity at the lowest tested dose combination and was not suitable for further study in this trial. Meanwhile, the MTD of concurrent gemcitabine/carboplatin chemoradiation was determined to be gemcitabine 450 mg/m and carboplatin AUC-2. This combination was found to be tolerable. Although not a primary end point, survival results are summarized as well.",
keywords = "Carboplatin, Chemoradiation, Concurrent chemoradiation, Gemcitabine, Non small cell lung cancer, NSCLC, Paclitaxel",
author = "Hak Choy and Jain, {Anshu K.} and Jennifer Moughan and Walter Curran and Gary Whipple and Demas, {William F.} and Ettinger, {David S}",
year = "2009",
month = "1",
doi = "10.1097/JTO.0b013e318191503f",
language = "English (US)",
volume = "4",
pages = "80--86",
journal = "Journal of Thoracic Oncology",
issn = "1556-0864",
publisher = "International Association for the Study of Lung Cancer",
number = "1",

}

TY - JOUR

T1 - RTOG 0017

T2 - 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

AU - Choy, Hak

AU - Jain, Anshu K.

AU - Moughan, Jennifer

AU - Curran, Walter

AU - Whipple, Gary

AU - Demas, William F.

AU - Ettinger, David S

PY - 2009/1

Y1 - 2009/1

N2 - PURPOSE: The optimal dose of gemcitabine that can be used with concurrent radiation therapy for locally advanced non-small cell lung cancer has not been well defined. This trial addresses this question in an alternating sequence "ping-pong" design trial to find the maximum tolerated dose (MTD) for gemcitabine/carboplatin (Sequence A) or gemcitabine/paclitaxel (Sequence B) and thoracic radiation therapy followed by adjuvant gemcitabine/carboplatin chemotherapy. PATIENTS AND METHODS: Thirty-five patients with histologically confirmed Stage IIIA/B non-small cell lung cancer were entered into two separate sequences, each with multiple cohorts. A dose level was considered acceptable if, of the first six eligible patients on each cohort, fewer than three experienced dose limiting toxicities. RESULTS: Sequence B of this 2 sequence "ping-pong" trial closed early due to toxicity in cohort 2 (gemcitabine 300 mg/m/wk and paclitaxel 30 mg/m/wk). On Sequence A, the MTD was the cohort 5 dose: gemcitabine 450 mg/m/wk and carboplatin 2 area under curve (AUC) concurrently with thoracic radiation. Cohort 7 (gemcitabine 600 mg/m/wk and carboplatin 2 AUC) showed 4 dose limiting toxicities: 2 grade 3 esophagitis; one grade 3 febrile neutropenia; and one grade 4 neutropenia. CONCLUSION: Concurrent gemcitabine/paclitaxel chemoradiation regimen followed by adjuvant gemcitabine/carboplatin produced excessive toxicity at the lowest tested dose combination and was not suitable for further study in this trial. Meanwhile, the MTD of concurrent gemcitabine/carboplatin chemoradiation was determined to be gemcitabine 450 mg/m and carboplatin AUC-2. This combination was found to be tolerable. Although not a primary end point, survival results are summarized as well.

AB - PURPOSE: The optimal dose of gemcitabine that can be used with concurrent radiation therapy for locally advanced non-small cell lung cancer has not been well defined. This trial addresses this question in an alternating sequence "ping-pong" design trial to find the maximum tolerated dose (MTD) for gemcitabine/carboplatin (Sequence A) or gemcitabine/paclitaxel (Sequence B) and thoracic radiation therapy followed by adjuvant gemcitabine/carboplatin chemotherapy. PATIENTS AND METHODS: Thirty-five patients with histologically confirmed Stage IIIA/B non-small cell lung cancer were entered into two separate sequences, each with multiple cohorts. A dose level was considered acceptable if, of the first six eligible patients on each cohort, fewer than three experienced dose limiting toxicities. RESULTS: Sequence B of this 2 sequence "ping-pong" trial closed early due to toxicity in cohort 2 (gemcitabine 300 mg/m/wk and paclitaxel 30 mg/m/wk). On Sequence A, the MTD was the cohort 5 dose: gemcitabine 450 mg/m/wk and carboplatin 2 area under curve (AUC) concurrently with thoracic radiation. Cohort 7 (gemcitabine 600 mg/m/wk and carboplatin 2 AUC) showed 4 dose limiting toxicities: 2 grade 3 esophagitis; one grade 3 febrile neutropenia; and one grade 4 neutropenia. CONCLUSION: Concurrent gemcitabine/paclitaxel chemoradiation regimen followed by adjuvant gemcitabine/carboplatin produced excessive toxicity at the lowest tested dose combination and was not suitable for further study in this trial. Meanwhile, the MTD of concurrent gemcitabine/carboplatin chemoradiation was determined to be gemcitabine 450 mg/m and carboplatin AUC-2. This combination was found to be tolerable. Although not a primary end point, survival results are summarized as well.

KW - Carboplatin

KW - Chemoradiation

KW - Concurrent chemoradiation

KW - Gemcitabine

KW - Non small cell lung cancer

KW - NSCLC

KW - Paclitaxel

UR - http://www.scopus.com/inward/record.url?scp=61549108337&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=61549108337&partnerID=8YFLogxK

U2 - 10.1097/JTO.0b013e318191503f

DO - 10.1097/JTO.0b013e318191503f

M3 - Article

C2 - 19096311

AN - SCOPUS:61549108337

VL - 4

SP - 80

EP - 86

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

SN - 1556-0864

IS - 1

ER -