Clinical trial NCT00040859: Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Official title: A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophageal Cancer
Gastric Cancer
Keywords: stage IV gastric cancer
recurrent gastric cancer
stage III esophageal cancer
stage IV esophageal cancer
recurrent esophageal cancer
adenocarcinoma of the stomach
adenocarcinoma of the esophagus
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: OBJECTIVES:

Primary

* Determine the objective tumor response rate of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with oxaliplatin and capecitabine.

Secondary

* Determine the time to progression and overall survival of patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
* Assess the quality of life of patients treated with this regimen.

OUTLINE: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Objective tumor response rate
timeFrame: Up to 3 years
Secondary outcomes:
measure: Time to progression
timeFrame: Up to 3 years
measure: Overall survival
timeFrame: Up to 3 years
measure: Quality of life
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Sioux City
country: United States
facility: Siouxland Hematology-Oncology Associates, LLP
state: Iowa
city: Sioux City
country: United States
facility: Mercy Medical Center - Sioux City
state: Iowa
city: Sioux City
country: United States
facility: St. Luke's Regional Medical Center
state: Iowa
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
city: Sioux Falls
country: United States
facility: Medical X-Ray Center, PC
state: South Dakota
city: Sioux Falls
country: United States
facility: Sanford Cancer Center at Sanford USD Medical Center
state: South Dakota
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.