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Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy.


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adenocarcinoma of the Esophagus, Adenocarcinomas of the Gastroesophageal Junction, Recurrent Esophageal Cancer, Squamous Cell Carcinoma of the Esophagus, Stage IV Esophageal Cancer

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Trial Information

Phase II Study of Pralatrexate and Docetaxel in Patients With Advanced Esophageal and Gastroesophageal Carcinoma Who Have Failed Prior Platinum-based Therapy.


PRIMARY OBJECTIVES:

I. To evaluate overall response rate (CR + PR as assessed by RECIST v 1.1) of the
combination of pralatrexate and docetaxel in patients with advanced esophageal and
gastroesophageal carcinomas.

SECONDARY OBJECTIVES:

I. Evaluation of progression free survival and overall survival. II. Correlation of FDG PET
response defined as a 35% reduction in SUV during the early course of chemotherapy to
progression free and overall survival in addition to radiographic response as measured by
RECIST v 1.1 criteria on CT imaging.

OUTLINE:

Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat
every 14 days in the absence of disease progression or unacceptable toxicity.

Inclusion Criteria


Inclusion

- Pathologically confirmed unresectable advanced or metastatic carcinoma of the
esophagus or gastroesophageal junction

- Established histological confirmation of squamous cell carcinoma or adenocarcinoma of
the esophagus or gastroesophageal junction

- Stage IV disease

- Must have received platinum-based therapy; this includes definitive, adjuvant and
metastatic treatments

- No more than 3 chemotherapeutic treatment regimens permitted; this includes
concurrent chemoradiation

- Radiation therapy allowed if > 4 weeks have elapsed

- Must be off therapy for 4 weeks prior to enrollment

- Measurable disease as defined by RECIST v 1.1 criteria

- ECOG PS of 0 to 2

- Predicted life expectancy of at least 12 weeks

- Patients with reproductive potential must use an effective method to avoid pregnancy
for the duration of the trial and for three months after completion of treatment

- Marrow: ANC > 1,000/mm^3

- Marrow: Hemoglobin > 9.0 g/dl

- Marrow: Platelet Count > 100,000/mm^3

- Renal: Serum creatinine =< 1.5 g/dL

- Hepatic: Serum bilirubin < 1.5 x ULN and AST and ALT =< 2.5 x ULN

- Prior minor surgeries (such as laparoscopies) must have occurred at least 14 days
prior to study enrollment; prior minor procedures such as biopsies and mediport
placement must have occurred at least 48 hours prior to study enrollment

- All patients must have signed an informed consent indicating that they are aware of
the neoplastic nature of their disease and have been informed of the procedures of
the protocol, the experimental nature of the therapy, alternatives, potential
benefits, side effects, risks, and discomforts

- History of allergic reactions attributed to compounds of similar chemical composition
to agents used in the study

Exclusion

- Pregnant or lactating women

- Patients with any severe concurrent disease which, in the judgment of the
investigator, would make the patient inappropriate for study entry

- Any malignant condition for which one has received treatment in the last two years
excluding squamous or basal cell carcinomas

- Patients with untreated brain metastases

- Patients must not have grade 2 or higher baseline peripheral neuropathy, according to
CTCAE v 4.0

- Patients must have NO continuing acute toxic effects (except alopecia) of any prior
radiotherapy, chemotherapy, or surgical procedures; all such effects must have
resolved to Common Terminology Criteria for Adverse Events (CTCAE v 4.0) Grade =< 1
prior to study enrollment

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall response

Outcome Time Frame:

Approximately three years

Safety Issue:

No

Principal Investigator

Jeffrey Rose

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-10018

NCT ID:

NCT01129206

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Esophagus
  • Adenocarcinomas of the Gastroesophageal Junction
  • Recurrent Esophageal Cancer
  • Squamous Cell Carcinoma of the Esophagus
  • Stage IV Esophageal Cancer
  • Gastroesophageal Cancer
  • Gastroesophageal Carcinoma
  • Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms

Name

Location

Ohio State UniversityColumbus, Ohio  43210