NCT01561014|CompletedPhase 1DMCFDA Drug

Oxaliplatin, Fluorouracil, Erlotinib Hydrochloride, and Radiation Therapy Before Surgery and Erlotinib Hydrochloride After Surgery in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

A Phase I Study of Preoperative Chemoradiation With Oxaliplatin, 5-Fluorouracil, Erlotinib and Radiation Followed by Resection and Consolidative Erlotinib for Patients With Locally Advanced Cancer of the Esophagus and Gastroesophageal Junction

Wake Forest University Health Sciences ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

IRB00007063

Secondary identifiers

NCI-2009-01447

REGISTRY · CTRP (Clinical Trial Reporting Program)

CCCWFU 60106

OTHER · Wake Forest University Health Sciences

Study Type

interventional

Actual enrollment (reported)

Locations

1 country

Sites

Timeline

Study Start

April 2007

Actual (reported)

Primary Completion

March 2009

Actual (reported)

Study Completion

March 2009

Actual (reported)

Brief Summary

This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with oxaliplatin, fluorouracil, and radiation before surgery and alone after surgery in treating patients with locally advanced cancer of the esophagus and gastroesophageal junction. Drugs used in chemotherapy, such as oxaliplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with erlotinib hydrochloride and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving erlotinib hydrochloride after surgery may kill any tumor cells that remain after surgery

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 9 participants
Study completion date: March 2009
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2007
Actual (reported)
Primary Completion
March 2009
Actual (reported)
Study Completion
March 2009
Actual (reported)
First Submitted
February 14, 2012
Actual (reported)
First Posted
March 22, 2012
Actual (reported)

Last Updated: July 2, 2018
Status Verified: June 2018
Last Update Submitted: June 29, 2018

Conditions

Adenocarcinoma of the Esophagus Adenocarcinoma of the Gastroesophageal Junction Adenocarcinoma of the Stomach Squamous Cell Carcinoma of the Esophagus

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Newly diagnosed patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology; patients should have evidence of extension of disease into or through the wall of the esophagus (T2-4) and/or regional nodal metastasis (N1)
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Non-pregnant; patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method); nursing mothers are also ineligible
Prior treatment: Greater than one week shall have elapsed since any major surgery; no prior chemotherapy or radiotherapy is allowed
Adequate whole blood cell (WBC) and platelets (Plt) as determined by medical oncology
Serum creatinine =\< 1.5 mg/dl
Creatinine clearance \>= 60 ml/min
Hemoglobin (Hgb) \>= 9.0 gm/dl
Absolute neutrophil count \>= 1,500/uL
Serum total bilirubin =\< 1.5 mg/dL
Alkaline phosphatase =\< 3X the upper limit of normal (ULN) for the reference lab
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than 2X ULN for the reference laboratory
Patients must be told of the investigational nature of the study and must sign a written informed consent
No serious medical or psychiatric illnesses which would prevent informed consent or otherwise limit survival to less than two years; no history of refractory congestive heart failure or cardiomyopathy
Patients should be evaluated by medical oncology, radiation oncology, and surgery, and felt to by all to be suitable for trimodality therapy

You may not qualify if:

Patients with an active infection or with a fever \>= 38.5 degrees Celsius (C) within 3 days of the first scheduled day of protocol treatment
History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate surface antigen (PSA) of \< 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
Patients with known hypersensitivity to any of the components of oxaliplatin
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)

Contact the study team to confirm eligibility.

Oxaliplatin, Fluorouracil, Erlotinib Hydrochloride, and Radiation Therapy Before Surgery and Erlotinib Hydrochloride After Surgery in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Treatment (chemotherapy, enzyme inhibitor therapy)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

Treatment (chemotherapy, enzyme inhibitor therapy)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations