Status:
COMPLETED
S1201: Combination Chemo for Patients W/Advanced or Metastatic Esophageal, Gastric, or Gastroesophageal Junction Cancer
Lead Sponsor:
SWOG Cancer Research Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, fluorouracil, irinotecan hydrochloride, and docetaxel, work in different ways to stop the growth of tumor cells, either ...
Detailed Description
OBJECTIVES: * To assess progression-free survival of high-excision repair cross-complementing 1(ERCC1) patients with advanced or metastatic cancer of the esophagus, stomach, or gastroesophageal junct...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Patients must have unresectable advanced or metastatic histologically or cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal junction (GEJ)
- Patients must not have received treatment for metastatic or unresectable disease
- Patients must not have brain metastases
- Patients must have measurable and/or non-measurable disease
- Patients who have had HER-2 expression testing prior to patient consent to this study must be HER-2 negative; if HER-2 expression has not been tested prior to patient consent to this study, a second specimen must be submitted for HER-2 expression; if the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will not be randomized
- Patients must have completed any prior neoadjuvant and adjuvant therapy for resectable disease at least 180 days prior to registration
- PATIENT CHARACTERISTICS:
- Zubrod performance status of 0-1
- Hemoglobin ≥ 9 g/dL
- Absolute neutrophil count (ANC) ≥ 1,500/mcL
- Platelets ≥ 100,000/mcL
- Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement secondary to tumor
- AST and ALT both ≤ 3 times institutional upper limit of normal (IULN) unless the liver is involved with tumor, in which case both AST and ALT must be ≤ 5 times IULN
- Serum creatinine \< 1.5 mg/dL within 28 days prior to registration AND/OR calculated creatinine clearance \> 60 mL/min
- Patients must not have motor or sensory neuropathy \> Grade 1 using CTCAE version 4.0
- Patients must not be pregnant or nursing; women and men of reproductive potential must have agreed to use an effective contraceptive method
- No other prior malignancy is allowed except for the following: adequately treated 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
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- All palliative radiation therapy alone must be completed at least 14 days prior to registration
- Patient must have no plans to receive concurrent chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer while on this protocol treatment
Exclusion
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2019
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT01498289
Start Date
February 1 2012
End Date
September 19 2019
Last Update
November 7 2019
Active Locations (508)
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1
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36688
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
Sutter Auburn Faith Hospital
Auburn, California, United States, 95602
4
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704