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
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
Other Clinical Trials
SWOG Clinical Trial Number
S2001
Parallel Randomized Phase II Clinical Trial of Olaparib + Pembrolizumab vs. Olaparib as Maintenance Therapy in Two Cohorts of Metastatic Pancreatic Cancer Patients with DNA Damage Repair Defects
Research Committee(s)
Gastrointestinal Cancer
Activated
12/04/2020
Accrual
0%
Open
Phase
II
SWOG Clinical Trial Number
CTSU/A021806
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Research Committee(s)
Gastrointestinal Cancer
Activated
07/01/2020
Open
SWOG Clinical Trial Number
S1922
Randomized Phase II Study of Ramucirumab and Paclitaxel versus FOLFIRI in Refractory Small Bowel Adenocarcinoma
Research Committee(s)
Gastrointestinal Cancer
Activated
12/16/2019
Accrual
9%
Open
Phase
II