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Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study

Phase 2
18 Years
Not Enrolling
Gastric Cancer

Thank you

Trial Information

Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study



- Compare the response rate in patients with "good risk" genotype (TSER*2/*2 or TSER*2/*3
genotype [low TS expression]) to historical control response rates in non-genotype
selected patients.

OUTLINE: This is a multicenter study.

Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and
fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses
repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.

Available tumor tissue samples are assessed for expression of TS at the mRNA and protein
levels. The results are correlated with germline and tumor TSER genotypes as well as
response to the study treatment regimen. Polymorphisms in other genes associated with
treatment outcome or toxicity are also assessed.

After completion of study treatment, patients are followed periodically for 4 years.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed adenocarcinoma of the
stomach or gastroesophageal junction

- Metastatic disease

- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded) as ≥
20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan

- No known active brain metastases

- Patients with treated brain metastases are eligible if stable off steroids for
at least 30 days


- ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)

- Life expectancy ≥ 3 months

- WBC ≥ 3,000/μL

- Absolute neutrophil count ≥ 1,500/μL

- Platelets ≥ 100,000/μL

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

- AST or ALT ≤ 2.5 x ULN (< 5 x ULN if known liver metastases)

- Creatinine clearance ≤ 1.5 x ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 21 days after
completion of study treatment

- No history of allergic reactions to fluorouracil or oxaliplatin

- No concurrent uncontrolled illness including, but not limited to, ongoing or active
infection or psychiatric illness/social situations that would limit compliance with
study requirements


- No prior therapy for metastatic disease

- Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval
has been longer than 6 months

- No other concurrent chemotherapy

- No concurrent combination anti-retroviral therapy for HIV-positive patients

- No concurrent routine prophylaxis with filgrastim (G-CSF)

- No other concurrent antineoplastic agents, including chemotherapy, radiation therapy,
or biologic agents

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])

Outcome Description:

Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions. This is a one-time assessment.

Outcome Time Frame:

every 8 weeks to progression

Safety Issue:


Principal Investigator

Laura W. Goff, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center


United States: Food and Drug Administration

Study ID:

VICC GI 0716



Start Date:

August 2007

Completion Date:

February 2011

Related Keywords:

  • Gastric Cancer
  • adenocarcinoma of the stomach
  • stage IV gastric cancer
  • recurrent gastric cancer
  • Stomach Neoplasms



Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill, North Carolina  27599-7570
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis St. Louis, Missouri  63110
Vanderbilt-Ingram Cancer Center - Cool Springs Nashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at Franklin Nashville, Tennessee  37064