A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01130337
First received: May 25, 2010
Last updated: September 1, 2015
Last verified: September 2015

May 25, 2010
September 1, 2015
July 2010
June 2014   (final data collection date for primary outcome measure)
Percentage of Participants With Disease-free Survival (DFS) at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
DFS was the time elapsed from the time of surgery (for complete resection [R0] participants) until the date on which progression or death from any cause was documented (whichever occured first). Progression was defined as target lesions greater than (>) 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded since the treatment started (nadir) and minimum 5 millimeter (mm) increase over the nadir. When the sum becomes very small, increases within the measurement error (2-3 mm) can lead to a 20% increase. Participants who did not present progression and who had not died were censored on the last date on which it was known that there was no progression (last response assessment).
Disease free survival defined as 18 months disease free survival rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01130337 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 ] [ Designated as safety issue: No ]
    pCR was defined as an absence of any invasive cancer cell of the primary tumor after the time of major neoadjuvant chemotherapy, with or without surgery.
  • Percentage of Participants With Complete Tumor Resection (R0) [ Time Frame: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 ] [ Designated as safety issue: No ]
    R0 resection was defined as having performed a complete resection of the tumor with adequate tumor-free margins and regional lymph node extirpation.
  • Percentage of Participants With Objective Response [ Time Frame: Between Days 7 and 21 of the 3rd cycle of neoadjuvant treatment, thereafter, every 9 weeks during adjuvant treatment and then after adjuvant treatment every 3 months until Month 25 ] [ Designated as safety issue: No ]
    An objective response was defined as either a complete response (CR) or a partial response (PR). Using the Response Evaluation Criteria in Solid Tumors (RECIST), CR was defined as the disappearance of all target lesions and all non-target lesions, normalization of tumor marker level, and no new lesions. PR was defined as the disappearance of all target lesions and persistence of greater than or equal to (≥) 1 non-target lesions and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing non-target lesions.
  • Pathological response according to Mandard criteria [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • R0 tumor resection rate [ Time Frame: Week 9 ] [ Designated as safety issue: No ]
  • Objective reponse rates according to RECIST criteria [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
  • Toxicity of treatment [ Time Frame: Every 3 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Capecitabine [Xeloda] in Combination With Trastuzumab [Herceptin] and Oxaliplatine in Patients With Resectable Gastric Cancer
An Open-label, Multi-center Study to Evaluate the Disease Free Survival Rate of a Perioperative Combination of Capecitabine (Xeloda), Trastuzumab (Herceptin) and Oxaliplatin (XELOX- Trastuzumab) in Patients With Resectable Gastric or Gastro-esophageal Junction Adenocarcinoma
This study will evaluate the disease free survival rate of a combination of capecitabine [Xeloda] and oxaliplatin (XELOX) with trastuzumab [Herceptin] in patients with resectable gastric cancer. The combination of Xeloda (orally, 1000 mg/m2 on day 1-14 of every cycle) and Herceptin (intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1-14 of every cycle) will be administered for three cycles prior to surgery to resect the tumor. If complete resection, R0 or microscopic residual tumor R1 is achieved, patients will continue with three cycles of XELOX and Herceptin and then for completion of 12 months treatment with Herceptin alone. Oxaliplatin will be administered intravenously at a dose of 130 mg/m2 on day 1 in every cycle. The anticipated time on study drug will be 12 months.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
  • Drug: Capecitabine [Xeloda]
    1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles
  • Drug: Oxaliplatin
    130 mg/m2 intravenous infusion day 1 of every cycle
  • Drug: Trastuzumab [Herceptin]
    First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles
Experimental: 1
Interventions:
  • Drug: Capecitabine [Xeloda]
  • Drug: Oxaliplatin
  • Drug: Trastuzumab [Herceptin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients over 18 years of age
  • Locally advanced resectable HER2-positive gastric or esophagogastric junction adenocarcinoma (Sievert types I, II, III)
  • Measurable (RECIST criteria) or assessable disease
  • ECOG performance 0-2
  • Life expectancy of 12 weeks or more

Exclusion Criteria:

  • Immeasurable lesion as the only evidence of disease
  • Previous chemotherapy or radiotherapy for gastric neoplasm or some kind of previous surgical resection of the tumor (except diagnostic laparoscopy)
  • Concomitant heart disease
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01130337
ML25189
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP