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Pharmacogenomic Study of Docetaxel and Cisplatin, Followed by Docetaxel, Cisplatin and Irradiation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00216008
Recruitment Status : Terminated (IRB Closure)
First Posted : September 22, 2005
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophageal Adenocarcinomas Adenocarcinomas of the Gastroesophageal Junction Drug: docetaxel Drug: cisplatin Procedure: radiation Procedure: surgery Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. response rate

Secondary Outcome Measures :
  1. toxicity and tolerability of this induction strategy
  2. time to progression
  3. surgical complication rate


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00216008


Locations
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United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Aventis Pharmaceuticals
Investigators
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Principal Investigator: Chris Garrett, MD H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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ClinicalTrials.gov Identifier: NCT00216008    
Other Study ID Numbers: MCC-13946
USFIRB#103493
IIT 14069
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: July 2009
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cisplatin
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action