- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00216008
Pharmacogenomic Study of Docetaxel and Cisplatin, Followed by Docetaxel, Cisplatin and Irradiation.
November 21, 2013 updated by: H. Lee Moffitt Cancer Center and Research Institute
Phase II Pharmacogenomic Study of Neoadjuvant Pre-irradiation Docetaxel and Cisplatin, Followed by Neoadjuvant Concomitant Docetaxel, Cisplatin and Irradiation, Followed by Surgery (CD-CDR-S) in Adult Patients With Operable Adenocarcinomas of the Esophagus or Gastroesophageal Junction
The purpose of this research study is to find out the effectiveness of the experimental combination of Docetaxel, Cisplatin, and radiation therapy administered prior to the surgical removal of your esophageal cancer.
Study Overview
Status
Terminated
Intervention / Treatment
Detailed Description
This study seeks to determine the safety and efficacy (the latter based on pathologic response rate, three- and five-year survival rates) of a three-phase multi-modality approach to adenocarcinomas of the esophagus or gastroesophageal junction.
This study also aims retrospectively to determine if a specific tumor gene array profile would predict for pathologic complete response.
Study schema is as follows.
Patients are first staged, next they receive induction Docetaxel and Cisplatin on days 1 and 22, patients are then restaged, next they will undergo radiation therapy combined with Cisplatin and Docetaxel for approximately days 42 thorough 84, patients are again restaged, and finally surgery at approximately days 100 to 150.
Study Type
Interventional
Enrollment
42
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center & Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have histological or cytological confirmed esophageal adenocarcinoma or adenocarcinoma of the gastroesophageal junction (this diagnosis will be rendered by the gastroenterology endoscopist, and refers to tumors at the junction of the esophagus and the stomach, where >50% of the tumor mass is above the diaphragm). Tumors must not have greater than 2cm extension into the the cardia.
- Stage T2N0M0, T3N0M0, T1-3N1M0, T1-3N0-1M1a as determined by imaging studies and endoscopic ultrasound staging. M1a disease (celiac nodal metastasis) is permitted if other eligibility criteria are met. Any lesion suspicious for metastasis should biopsied (either by tru cut or fine needle aspiration) to prove eligibility.
- The subject has been deemed an appropriate surgical candidate by one of the surgical subinvestigators (ie. Not T4).
- No medical comorbidity making the patient not a surgical candidate.
- Subject must be 18 years or older
- Subject must understand the consent and be willing to give written and informed consent to participate in this investigational protocol, and for a tumor biopsy to be performed for research purposes at the time of their staging endoscopic ultrasound (clinically required for their care), and for a portion of their resection specimen be subjected to experimental laboratory analysis
- ECOG performance status <1 (Karnofsky >80%; see Appendix A).
- Subjects must have adequate caloric intake, as determined by a nutrition evaluation by a registered dietician. Nutrition intake may be enteral, hyperalimentation by enteral feeding tube, or by parenteral nutrition.
- Patients must have normal organ and marrow function as defined as: leukocytes >3,000/mcL; absolute neutrophil count >1,500/mcL; platelets >100,000/mcL; hemoglobin > 8 g/dl; Creatinine clearance (estimated by Cockroft-Gault equation) >50-mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Hepatic: Total bilirubin must be < ULN; AST and ALT and alkaline phosphatase must both be less than 2.5 x ULN.
- Has a negative serum or urine pregnancy test within 7 days prior to initiation of therapy (female patients of childbearing potential).
Exclusion Criteria:
- Patients may not be receiving any other investigational agents.
- Common Toxicity Criteria Adverse Events version 3 (CTCAEv3) greater than grade 1 peripheral neuropathy.
- Uncontrolled intercurrent illness 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. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months.
- Pregnant and nursing women are excluded from this study. Women / men of childbearing potential not using a reliable and appropriate contraceptive method. Woman of childbearing potential with either a positive or no pregnancy test at baseline. (Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients will agree to continue contraception for 30 days from the date of the last study drug administration
- Patients with a history of severe hypersensitivity reaction to docetaxel, cisplatin, or drugs formulated with polysorbate (Tween) 80.
- Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with cisplatin and docetaxel or other agents administered during the study.
- Major surgery within 4 weeks of the start of study treatment, without complete recovery.
- History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
- Clinical or radiographic evidence of a tracheobronchial fistula or invasion of the aorta (i.e. T4 disease).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
response rate
|
Secondary Outcome Measures
Outcome Measure |
---|
toxicity and tolerability of this induction strategy
|
time to progression
|
surgical complication rate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Chris Garrett, MD, H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
February 1, 2007
Study Completion (Actual)
February 1, 2007
Study Registration Dates
First Submitted
September 19, 2005
First Submitted That Met QC Criteria
September 19, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
November 25, 2013
Last Update Submitted That Met QC Criteria
November 21, 2013
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-13946
- USFIRB#103493
- IIT 14069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Esophageal Adenocarcinomas
-
PfizerTerminatedGastrointestinal Tumors | Esophageal Adenocarcinomas | Colorectal Adenocarcinomas | Gastric AdenocarcinomasUnited States, Australia, Japan
-
National Center for Tumor Diseases, HeidelbergTerminatedAdenocarcinomas of the Esophagogastric JunctionGermany
-
University of Lausanne HospitalsCompletedPancreas AdenocarcinomasSwitzerland
-
Ohio State University Comprehensive Cancer CenterNational Comprehensive Cancer Network; Spectrum Pharmaceuticals, IncCompletedSquamous Cell Carcinoma of the Esophagus | Adenocarcinomas of the Gastroesophageal Junction | Adenocarcinoma of the Esophagus | Recurrent Esophageal Cancer | Stage IV Esophageal CancerUnited States
-
MedImmune LLCCompletedGastrointestinal AdenocarcinomasUnited States
-
University Hospital, Strasbourg, FranceRecruitingGastric and Cardia AdenocarcinomasFrance
-
Centre Hospitalier Saint Joseph Saint Luc de LyonCompletedPrevalence of Pancreas AdenocarcinomasFrance
-
National University Hospital, SingaporeRecruitingAdenocarcinomas | Recurrent GynecologicalSingapore
-
National Cancer Institute (NCI)CompletedBreast Cancer | Breast Neoplasms | Adenocarcinomas | Metastatic Solid Tumors Characterized by HER2/Neu ExpressionUnited States
-
Accelerated Community Oncology Research NetworkAmgenTerminatedGastroesophageal Adenocarcinoma | Adenocarcinomas of the Gastroesophageal Junction | Adenocarcinoma of the Distal Esophagus | Adenocarcinoma of the Proximal StomachUnited States
Clinical Trials on docetaxel
-
Nereus Pharmaceuticals, Inc.CompletedCancerUnited States, Australia, India, Chile, Brazil, Argentina
-
Tianjin Medical University Cancer Institute and...Recruiting
-
Zhuhai Beihai Biotech Co., LtdCompletedSolid Tumours | Bioequivalence | DocetaxelIndia
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaCompletedNon-Small Cell Lung Cancer (NSCLC)China
-
National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaboratorsUnknownGastric CancerKorea, Republic of
-
Optimal Health ResearchCompletedBreast Cancer | Lung Cancer | Prostate CancerUnited States
-
Arog Pharmaceuticals, Inc.WithdrawnCarcinoma, Non-Small-Cell Lung
-
Boehringer IngelheimCompletedCarcinoma, Non-Small-Cell LungJapan
-
SanofiCompleted
-
SanofiCompletedLung NeoplasmsFrance, Netherlands, Spain, Turkey, Belgium, Finland, Italy, United Kingdom