NCT00040859

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2002

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2002

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

2.3 years

First QC Date

July 8, 2002

Last Update Submit

December 5, 2016

Conditions

Esophageal CancerGastric Cancer

Keywords

stage IV gastric cancerrecurrent gastric cancerstage III esophageal cancerstage IV esophageal cancerrecurrent esophageal canceradenocarcinoma of the stomachadenocarcinoma of the esophagus

Outcome Measures

Primary Outcomes (1)

  • Objective tumor response rate

    Up to 3 years

Secondary Outcomes (3)

  • Time to progression

    Up to 3 years

  • Overall survival

    Up to 3 years

  • Quality of life

    Up to 3 years

Study Arms (1)

oxaliplatin + capecitabine

EXPERIMENTAL

Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR. Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy). Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Drug: capecitabineDrug: oxaliplatin

Interventions

capecitabineDRUG
oxaliplatin + capecitabine
oxaliplatinDRUG
oxaliplatin + capecitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists * Unresectable disease * Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach * Measurable disease * No known CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than upper limit of normal (ULN) * AST no greater than 3 times ULN * Alkaline phosphatase no greater than 2 times ULN Renal: * Creatinine no greater than 1.5 times ULN * Creatinine clearance at least 60 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease Other: * Able to swallow capecitabine * No unresolved gastrointestinal bleeding * No uncontrolled infection * No chronic debilitating disease * No peripheral neuropathy grade 2 or greater * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy or biological therapy for recurrent or metastatic disease * No concurrent biologic agents Chemotherapy: * No prior chemotherapy for recurrent or metastatic disease * Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Chemotherapy * No prior radiotherapy for recurrent or metastatic disease * No prior radiotherapy to more than 25% of the bone marrow * Prior adjuvant or neoadjuvant radiotherapy allowed * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery: * More than 4 weeks since prior abdominal exploration with surgical resection * More than 3 weeks since prior abdominal exploration without surgical resection Other: * No concurrent oral cryotherapy during oxaliplatin administration

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Siouxland Hematology-Oncology Associates, LLP

Sioux City, Iowa, 51101, United States

Location

Mercy Medical Center - Sioux City

Sioux City, Iowa, 51104, United States

Location

St. Luke's Regional Medical Center

Sioux City, Iowa, 51104, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Medical X-Ray Center, PC

Sioux Falls, South Dakota, 57105, United States

Location

Sanford Cancer Center at Sanford USD Medical Center

Sioux Falls, South Dakota, 57117-5039, United States

Location

Related Publications (2)

  • Jatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535.

    PMID: 20126980BACKGROUND

  • Jatoi A, Murphy BR, Foster NR, Nikcevich DA, Alberts SR, Knost JA, Fitch TR, Rowland KM Jr; North Central Cancer Treatment Group. Oxaliplatin and capecitabine in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia: a phase II study from the North Central Cancer Treatment Group. Ann Oncol. 2006 Jan;17(1):29-34. doi: 10.1093/annonc/mdj063. Epub 2005 Nov 22.

    PMID: 16303863RESULT

MeSH Terms

Conditions

Esophageal NeoplasmsStomach NeoplasmsAdenocarcinoma Of Esophagus

Interventions

CapecitabineOxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesCoordination ComplexesOrganic Chemicals

Study Officials

  • Aminah Jatoi, MD

    Mayo Clinic

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2002

First Posted

January 27, 2003

Study Start

September 1, 2002

Primary Completion

January 1, 2005

Study Completion

April 1, 2008

Last Updated

December 7, 2016

Record last verified: 2016-12

Locations

US(6)