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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

Phase 2
18 Years
Not Enrolling
Esophageal Adenocarcinomas, Adenocarcinomas of the Gastroesophageal Junction

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Trial Information

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

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.

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

- History of clinically significant interstitial lung disease and/or pulmonary

- 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).

Type of Study:


Study Design:

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

Outcome Measure:

response rate

Principal Investigator

Chris Garrett, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

February 2007

Related Keywords:

  • Esophageal Adenocarcinomas
  • Adenocarcinomas of the Gastroesophageal Junction
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Esophageal Diseases



H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612