Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction Carcinoma
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|ClinicalTrials.gov Identifier: NCT00256321|
Recruitment Status : Terminated (Closed due to poor accrual)
First Posted : November 21, 2005
Last Update Posted : February 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Gastric Carcinoma Gastroesophageal Junction Carcinoma||Drug: Oxaliplatin Drug: Capecitabine Drug: Celecoxib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Celecoxib/Oxaliplatin/Capecitabine Combination Chemotherapy for Unresectable,Recurrent, or Metastatic Gastric/Gastroesophageal Junction Carcinoma|
|Study Start Date :||October 2004|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
Oxaliplatin 70mg/m2 IV on Days 1 and 8. Capecitabine 1000mg/m2 PO BID from Days 1 through 14. Celecoxib 400mg PO BID from Days 1 through 21.
1 Cycle = 21 days.
Oxaliplatin 70mg/m2 IV on Days 1 and 8
Other Name: Eloxatin
Capecitabine 1000mg/m2 PO BID from Days 1 through 14.
Other Name: Xeloda
Celecoxib 400mg PO BID from Days 1 through 21.
Other Name: Celebrex
- Response rate of patients with gastric/gastroesophageal carcinoma when treated with celecoxib, oxaliplatin, and capcetabine combination therapy [ Time Frame: 18 weeks ]
Complete Response (CR) Complete disappearance of all measurable and evaluable disease. No new lesions. No disease related symptoms. No evidence of non evaluable disease, including normalization of markers and other abnormal lab values. All measurable, evaluable and non evaluable lesions and sites must be assessed using the same techniques as baseline.
Partial Response (PR): Applies only to patients with at least one measurable lesion. Greater than or equal to 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No progression of evaluable disease. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline.
A response rate (RR) is defined as a complete or partial response. RR=CR+PR
- Determine time to progression [ Time Frame: 18 weeks ]Progression: 50% increase or an increase of 10 CM2 (whichever is smaller) in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion which had disappeared, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). For "scan only" bone disease, increased uptake does not constitute clear worsening. Worsening of existing non evaluable disease does not constitute progression.
- Incidence of treatment-related study adverse events and toxicity according to NCI Common Toxicity Criteria v2.X [ Time Frame: 18 weeks ]Toxicity and adverse events are graded on CTC (NCI Common Toxicity Criteria) version 2.X.
- Evaluate the expression of the Cox-2 on paraffin-embedded tumor sections from patients enrolled on the study and correlate expression with clinical response [ Time Frame: 18 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256321
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Randall Holcombe, MD||Chao Family Comprehensive Cancer Center|