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A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1(Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer

Phase 2
18 Years
Open (Enrolling)
Adenocarcinoma of the Gastroesophageal Junction, Esophageal Cancer, Gastric Cancer

Thank you

Trial Information

A Randomized Phase II Pilot Study Prospectively Evaluating Treatment for Patients Based on ERCC1(Excision Repair Cross-Complementing 1) for Advanced/Metastatic Esophageal, Gastric or Gastroesophageal Junction (GEJ) Cancer


- To assess progression-free survival of high-excision repair cross-complementing
1(ERCC1) patients with advanced or metastatic cancer of the esophagus, stomach, or
gastroesophageal junction (GEJ) treated with FOLFOX comprising oxaliplatin, leucovorin
calcium, and fluorouracil compared to those treated with irinotecan hydrochloride plus

- To assess progression-free survival of low-ERCC1 patients with advanced or metastatic
cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to those treated
with irinotecan hydrochloride plus docetaxel.

- To assess progression-free survival of low-ERCC1 patients with advanced or metastatic
cancer of the esophagus, stomach, or GEJ treated with FOLFOX compared to high-ERCC1
patients treated with FOLFOX.

- To assess overall survival of and toxicities in each of the two treatment arms in this
group of patients.

- To assess the response probability (confirmed and unconfirmed, complete and partial
responses) in the subset of patients with measurable disease in each of the two
treatment arms.

- To explore whether there is evidence of interaction between treatment arm and ERCC1
expression in this group of patients. (Exploratory)

- To bank tissue and blood for future translational medicine studies; a) To explore the
relationship of ERCC-1 and ERCC-2 single nucleotide polymorphism (SNP) genotypes with
clinical outcome in these patients; and b) To explore the association between germline
variations in these SNPs and ERCC-1 mRNA expression in these patients. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to ERCC1 expression
(high [≥ 1.7] vs low [< 1.7]), and disease site (esophageal vs gastric/gastroesophageal
junction). Patients are randomized to 1 of 2 treatment arms.

- Arm I (FOLFOX): Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV
over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Courses repeat
every 14 days in the absence of disease progression or unacceptable toxicity.

- Arm II: Patients receive irinotecan hydrochloride IV over 90 minutes and docetaxel IV
over 30-60 minutes on days 1 and 8. Courses repeat every 21 days in the absence of
disease progression or unacceptable toxicity.

Blood and tumor tissue samples may be collected for ERCC1 expression analysis and future
research studies.

After completion of study treatment, patients are followed up every 3 months for up to 3

Inclusion Criteria


- Patients must have unresectable advanced or metastatic histologically or
cytologically confirmed adenocarcinoma of the esophagus, stomach, or gastroesophageal
junction (GEJ)

- Patients must not have received treatment for metastatic or unresectable disease

- Patients must not have brain metastases

- Patients must have measurable and/or non-measurable disease

- Patients who have had HER-2 expression testing prior to patient consent to this study
must be HER-2 negative; if HER-2 expression has not been tested prior to patient
consent to this study, a second specimen must be submitted for HER-2 expression; if
the specimen is HER-2 positive (or if HER-2 could not be evaluated), the patient will
not be randomized

- Patients must have completed any prior neoadjuvant and adjuvant therapy for
resectable disease at least 180 days prior to registration


- Zubrod performance status of 0-1

- Hemoglobin ≥ 9 g/dL

- Absolute neutrophil count (ANC) ≥ 1,500/mcL

- Platelets ≥ 100,000/mcL

- Total bilirubin ≤ 1.5 mg/dL regardless of whether patients have liver involvement
secondary to tumor

- AST and ALT both ≤ 3 times institutional upper limit of normal (IULN) unless the
liver is involved with tumor, in which case both AST and ALT must be ≤ 5 times IULN

- Serum creatinine < 1.5 mg/dL within 28 days prior to registration AND/OR calculated
creatinine clearance > 60 mL/min

- Patients must not have motor or sensory neuropathy > Grade 1 using CTCAE version 4.0

- Patients must not be pregnant or nursing; women and men of reproductive potential
must have agreed to use an effective contraceptive method

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for five years


- See Disease Characteristics

- All palliative radiation therapy alone must be completed at least 14 days prior to

- Patient must have no plans to receive concurrent chemotherapy, hormonal therapy,
radiotherapy, immunotherapy, or any other type of therapy for treatment of cancer
while on this protocol treatment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) between high-ERCC1 and low-ERCC1 patients treated with FOLFOX versus irinotecan hydrochloride plus docetaxel

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

Syma Iqbal, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

February 2012

Completion Date:

March 2019

Related Keywords:

  • Adenocarcinoma of the Gastroesophageal Junction
  • Esophageal Cancer
  • Gastric Cancer
  • recurrent esophageal cancer
  • stage IV esophageal cancer
  • recurrent gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the gastroesophageal junction
  • stage IIIB gastric cancer
  • stage IIIC gastric cancer
  • stage IIIB esophageal cancer
  • stage IIIC esophageal cancer
  • adenocarcinoma of the esophagus
  • adenocarcinoma of the stomach
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms



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