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A Single-Arm, Phase II Study of Tarceva Plus FOLFOX6 in Patients With Unresectable or Metastatic Cancer of Esophagus or Gastroesophageal Junction

Phase 2
18 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

A Single-Arm, Phase II Study of Tarceva Plus FOLFOX6 in Patients With Unresectable or Metastatic Cancer of Esophagus or Gastroesophageal Junction

More than 50% of patients with advanced esophageal cancer present with disease that cannot
be removed by surgery or has spread to other parts of the body. Improved therapies for
patients with advanced esophageal cancer are therefore urgently needed. The epidermal growth
factor receptor (EGFR) inhibitor erlotinib (in combination with chemotherapy) has lead to
improved survival in patients with pancreatic and lung cancer. EGFR is a target in
esophageal cancer therapy since its overexpression is associated with more aggressive
disease and poor survival. Early studies have shown some clinical activity of EGFR
inhibitors in this disease alone or in combination with chemotherapy. This study aims to
explore how safe and effective treatment with erlotinib and FOLFOX is in patients with
advanced esophageal or gastro-esophageal cancer.

Inclusion Criteria:

- Histologically confirmed esophageal carcinoma (squamous or adenocarcinoma).

- Surgically unresectable disease and/or metastatic disease. Endoscopic accessibility
of primary tumor preferred but not a prerequisite.

- No prior chemotherapy therapy except for neoadjuvant treatment (radiation and/or
chemotherapy). Prior treatment with EGFR-inhibiting agents NOT allowed.

- Life expectancy >12 weeks.

- Ability to take and retain oral medications, or have an appropriate percutaneous
feeding tube in place.

- ECOG performance status of 0, 1, or 2 (Karnofsky Performance Status [KPS] ≥50%).

- Measurable disease by RECIST criteria and computerized tomographic scan performed
within 28 days prior to registration.

- Organ system function assessed within 7 days prior to registration and within the
following parameters:

- Absolute neutrophil count ≥ 1500/mL;

- Platelet count ≥ 100,000/mL;

- Hemoglobin level ≥ 10.0 gm/dL;

- Serum creatinine ≤ 1.5 x IULN (Institutional Upper Limits of Normal); OR Measured
creatinine clearance ≥ 60 mL/min;

- AST (SGOT) or ALT (SGPT) ≤ 2.5 x IULN (unless the liver is involved by tumor, in
which case it must be ≤ 5.0 x IULN);

- Total bilirubin ≤ 1.5 x IULN.

- Aged 18 years or older

- Provision of written informed consent

- Women of childbearing potential (WOCBP) must be willing to practice acceptable
methods of birth control to prevent pregnancy. WOCBP are any females who have
experienced menarche and who have not undergone surgical sterilization (hysterectomy,
bilateral tubal ligation, or bilateral oophorectomy), who are not postmenopausal
(defined as amenorrhea greater than or equal to 12 consecutive months), or are on
hormone replacement therapy. Acceptable methods of birth control include oral or
hormonal contraceptives and barrier methods (e.g., condom, diaphragm) used in
combination with other methods (e.g., spermicide).

- Male patients who are capable of fathering a child must avoid doing so while
participating in this study through the use of acceptable methods of birth control.
This is a precautionary measure because this study involves chemotherapy agents.

Exclusion Criteria:

- Presence of a Kras mutation.

- Lack of expression of EGFR.

- Prior treatment with EGFR-inhibiting agents, chemotherapy, or radiotherapy for
esophagogastric carcinomas (other than neoadjuvant treatment as noted in inclusion

- Patients must not be receiving any other investigational agents. Use of
erythropoietin is allowable. Secondary prophylaxis with granulocyte colony
stimulating factor (G-CSF) (Filgrastim) is allowable.

- Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital,
or St. John's wort.

- Uncontrolled brain metastases.

- Patients must not have uncontrolled intercurrent illness at the time of registration
including, but not limited to, ongoing or active infection, symptomatic congestive
heart failure, unstable angina, pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements.

- Patients must not have current New York Heart Association Class III or IV heart

- Known human immunodeficiency virus (HIV) infection.

- Pregnant or breast-feeding women.

- Patients who have had prior malignancies, except non-melanoma skin cancer (basal or
squamous cell carcinoma) are not eligible for this study; unless greater than 5 years
has passed since the event.

- Known severe hypersensitivity to Tarceva.

- Treatment with a non-approved or investigational drug within 30 days before Day 1 of
trial treatment.

- Incomplete healing from previous oncologic or other major surgery.

- Serum creatinine level greater than Common Toxicity Criteria (CTC) grade 2.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS)

Outcome Description:

To determine the number of participants with progression free survival after 6 months form the first day of the Erlotinib Run-In Phase for patients treated on study.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

W. Michael Korn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Francisco


United States: Institutional Review Board

Study ID:




Start Date:

October 2007

Completion Date:

May 2011

Related Keywords:

  • Esophageal Cancer
  • metastatic esophageal cancer
  • erlotinib
  • folfox
  • advanced esophageal cancer
  • unresectable esophageal cancer
  • Esophageal Diseases
  • Esophageal Neoplasms



UCSF Comprehensive Cancer CenterSan Francisco, California  94115