Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy

NCT ID: NCT01129206

Last Updated: 2016-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31

Brief Summary

RATIONALE: Pralatrexate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving pralatrexate together with docetaxel may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving pralatrexate together with docetaxel works in treating patients with stage IV esophageal or gastroesophageal cancer who have failed platinum-based therapy.

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate overall response rate CR & PR(Complete Response + Partial Response)as assessed by RECIST (Response Evaluation Criteria in Solid Tumors 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(fludeoxyglucose)PET(positron emission tomography)response defined as a 35% reduction in SUV(standard uptake value)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.

Conditions

Adenocarcinoma of the Esophagus; Adenocarcinomas of the Gastroesophageal Junction; Recurrent Esophageal Cancer; Squamous Cell Carcinoma of the Esophagus; Stage IV Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

pralatrexate

Intervention Type: DRUG

IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.

docetaxel

Intervention Type: DRUG

Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.

fludeoxyglucose F 18

Intervention Type: RADIATION

Correlative studies

positron emission tomography

Intervention Type: PROCEDURE

Correlative studies

Interventions

pralatrexate

IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.

Intervention Type: DRUG

docetaxel

Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.

Intervention Type: DRUG

fludeoxyglucose F 18

Correlative studies

Intervention Type: RADIATION

positron emission tomography

Correlative studies

Intervention Type: PROCEDURE

Other Intervention Names

FOLOTYN; PDX; RP 56976; Taxotere; TXT; 18FDG; FDG; Fluorine-18 2-Fluoro-2-deoxy-D-Glucose; fluorodeoxyglucose F 18; FDG-PET; PET; PET scan; tomography, emission computed

Eligibility Criteria

Inclusion Criteria

• 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 (Eastern Cooperative Oncology Group)PS(Performance status)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(absolute neutrophil count)> 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(upper limit of normal) and AST (aspartate aminotransferase) and ALT (Alanine aminotransferase)=< 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Comprehensive Cancer Network

NETWORK

Sponsor Role: collaborator

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Tony Bekaii-Saab

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tony Saab, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Ohio State University

Columbus, Ohio, United States

Countries

United States

References

Petullo B, Wei L, Yereb M, Neal A, Rose J, Bekaii-Saab T, Wu C. A phase II study of biweekly pralatrexate and docetaxel in patients with advanced esophageal and gastroesophageal carcinoma that have failed first-line platinum-based therapy. J Gastrointest Oncol. 2015 Jun;6(3):336-40. doi: 10.3978/j.issn.2078-6891.2015.011.

Reference Type: BACKGROUND

PMID: 26029462 (View on PubMed)

Related Links

http://cancer.osu.edu

Jamesline

Other Identifiers

NCI-2010-01225

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-10018

Identifier Type: -

Identifier Source: org_study_id