SWOG clinical trial number
S1201

A Randomized Phase II Pilot Study Prospectively Evaulating Treatment for Patients Based on ERCC1 (Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer

Closed
Phase
Accrual
95%
Abbreviated Title
Phase II Rando Trt Based on ERCC1 for Advanced/Met Gastric Ca or Gastroesophageal Junction (GEJ) Ca
Activated
02/08/2012
Closed
04/01/2015
Participants
NCORP, Members, Medical Oncologists, CTSU, Affiliates

Research committees

Gastrointestinal Cancer

Treatment

5-Fluorouracil Docetaxel Irinotecan Leucovorin Calcium Oxaliplatin

Eligibility Criteria Expand/Collapse

Unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ) and no brain metastases. Pts must not have received treatment for metastatic or unresectable disease. Measurable and/or non-measurable disease. HER-2 negative (if not already tested, will be performed with ERCC1 testing). Tumor available for ERCC1 (and HER-2, if needed) testing. Any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to reg. Zubrod performance status 0-1. Within 28 days prior to registration: hemoglobin >/= 9 g/dL; ANC >/= 1,500/mcL; platelets >/= 100,000/mcL; total bilirubin </= 1.5 mg/dL; AST and ALT both </= 3.0 x IULN (5.0 x IULN for liver mets); serum creatinine < 1.5 mg/dL OR creatinine clearance > 60 ml/min. Pt must not have motor or sensory neuropathy > Grade 1 using CTCAE v4.0. Pt must not have plans to receive concurrent chemotherapy, radiotherapy, immunotherapy or any other type of therapy for treatment of cancer while on protocol treatment. Palliative radiation therapy alone must be completed at least 14 days prior to registration. Prestudy history/physical performed within 28 days prior to reg. Must not be pregnant or nursing. No other prior malignancy is allowed except the following: adequately treatment basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for five years.

Publication Information Expand/Collapse

2020

A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients with Advanced/ Metastatic Esophageal, Gastric or Gastroesophageal Junction Cancer Based on Gene Expression of ERCC1: SWOG S1201

S Iqbal;S McDonough;H-J Lenz;D Ilson;C Nangia;A Barzi;CJ Schneider;J Liu;E Dotan;K Guthrie;H Hochster Journal of Clinical Oncology Feb 10;38(5):472-479

PMid: PMID31815582 | PMC number: PMC7007287

2017

A randomized phase II pilot study prospectively evaluating treatment for patients based on ERCC1 (Excision Repair Cross-Complementing 1) for advanced/ metastatic esophageal, gastric or gastroesophageal junction (GEJ) cancer: SWOG S1201

S Iqbal;S McDonough;H Lenz;D Ilson;B Burtness;CS Nangia;A Barzi;CJ Schneider;J Liu;E Dotan;K Guthrie;H Hochster J Clin Oncol 35, 2017 (suppl; abstr 4009); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), poster discussion

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Research Committee(s)
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Activated
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SWOG Clinical Trial Number
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Research Committee(s)
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Activated
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Accrual
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Open
Phase
II