Neoplasms

All Conditions

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

docetaxel

cisplatin

radiation

surgery

Chris Garrett, MD

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.

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.

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

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

Aventis Pharmaceuticals

H. Lee Moffitt Cancer Center and Research Institute

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma, Squamous Cell

Esophageal Neoplasms

Recurrence

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Anti-Infective Agents

Fluorides

Fluorodeoxyglucose F18

Deoxyglucose

Radiopharmaceuticals

Antimetabolites

Antiviral Agents

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.

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

pralatrexate

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

positron emission tomography

Tony Saab, MD

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.

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.

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

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

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

OS was determined from the date of start of therapy to death frm any cause.

Radiological assessment of tumor response was performed by computed tomography (CT) and positron emission tomography (PET) every four cycles of therapy and responses were measured according to RECIST and PERCIST criteria.

National Comprehensive Cancer Network

Spectrum Pharmaceuticals, Inc

Ohio State University Comprehensive Cancer Center

Principal Investigator

Toxicities were defined by the National Cancer Institutes CTCAE version 3.0

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.

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

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.

fludeoxyglucose F 18: Correlative studies

positron emission tomography: Correlative studies

Arm I

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Tanios Bekaii Saab, MD

Stable disease

Progressive disease

Arm I: Pralatrexate and Docetaxel

Overall Response

Progression-free Survival (PFS)

Overall Survival (OS)

Progressive Disease

Stable Disease

Partial Response

PERCIST Criteria Per PET

RECIST Criteria Per CT

2 patients not evaluable for response applying the PERCIST criteria per PET

Correlation of FDG PET Response With Response Rate

Overall Study

Paclitaxel

Carboplatin

Fluorouracil

Albumin-Bound Paclitaxel

Panitumumab

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Immunological

Panitumumab 9mg/kg on Days 1, 22, and 43

Paclitaxel 200mg/m2 on Days 1 and 22

Carboplatin AUC=6 on Days 1 and 22

5FU 225mg/m2/day on Days 1-15 and 22-36

Robert Hermann, MD

This is an open-label, Phase II, single-stage study evaluating the use of panitumumab, paclitaxel, carboplatin and 5FU as an induction regimen in subjects with gastroesophageal adenocarcinoma. The expectation is that this combination will both increase potential overall survival by incorporating novel biologic therapy in the neoadjuvant setting and decrease potential surgical mortality by eliminating pre-operative radiation therapy.

Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

A Phase II Study of Pre-operative Panitumumab, Paclitaxel, Carboplatin and Continuous Infusion 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma

The primary endpoint is overall response rate (ORR) as determined per RECIST guidelines version 1.1 from baseline and restaging scans conducted between Days 36 to 43. Response is defined as the occurrence of either Complete Response (CR) or Partial Response (PR) as best response. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. A PR is defined as at least a 30% decrease in the sum of diameters of the target lesions taking as reference the baseline sum diameters.

The patient will be scored as having had a pathologic complete response (pCR) if the routine histologic examination of the resected specimen shows no residual invasive cancer by standard hematoxylin and eosin (H\&E) examination.

The patient will be scored as having an R0 resection, if no invasive cancer is detected involving the margins of the resection by routine microscopic hematoxylin and eosin (H\&E)examination, and the operative report indicates complete resection with no residual disease.

The patient will be scored as having an R1 resection, if invasive cancer is detected involving the margins of resection by routine microscopic hematoxylin and eosin (H\&E) examination, and the operative report indicates complete resection with no residual disease.

The patient will be scored as having an R2 resection, if the operative report indicates incomplete resection or gross residual disease.

All subjects who have undergone surgical resection will be followed for a 30-day postoperative safety evaluation. Death from any cause within 30 days of the date of surgery will be considered a surgical mortality death.

Amgen

Accelerated Community Oncology Research Network

Systematic Assessment- subjects were assessed for adverse events on day 1 of each cycle by either the research coordinator, treating physician, or other appropriate sub-investigator.

Panitumumab 9mg/kg on Days 1, 22, and 43; Paclitaxel 200mg/m2 on Days 1 and 22; Carboplatin AUC=6 on Days 1 and 22; 5FU 225mg/m2/day on Days 1-15 and 22-36

Treatment Group: Panitumumab, Paclitaxel, Carboplatin and 5FU

Panitumumab 9mg/kg on Days 1, 22, and 43

Paclitaxel 200mg/m2 on Days 1 and 22

Carboplatin AUC=6 on Days 1 and 22

5FU 225mg/m2/day on Days 1-15 and 22-36

Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43

Paclitaxel 200mg/m2 on Days 1 and 22

Carboplatin AUC=6 on Days 1 and 22

5FU 225mg/m2/day on Days 1-15 and 22-36

Treatment Group

Age, Categorical

Age Continuous

This study was closed due to notification and preliminary results from a trial including panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the PI, Sponsor, and Funder.

Vice Presidnet of Scientific Affairs

This study was closed due to a notification letter (November 1, 2011) and preliminary results from another trial that included panitumumab as part of combination chemotherapy for gastroesophageal cancer. The study was closed by mutual consent from the Principal Investigator, Sponsor, and Funder.

Response Rate

Pathologic Response Rate

Resection Rate of Surgery

Thirty-day Surgical Mortality

Survival

Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43

Paclitaxel 200mg/m2 on Days 1 and 22

Carboplatin AUC=6 on Days 1 and 22

5FU 225mg/m2/day on Days 1-15 and 22-36

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacogenomic Study of Docetaxel and Cisplatin, Followed by Docetaxel, Cisplatin and Irradiation.	NCT00216008	Esophageal Aden... Adenocarcinomas...	docetaxel cisplatin radiation surgery	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy	NCT01129206	Adenocarcinoma ... Adenocarcinomas... Recurrent Esoph... Squamous Cell C... Stage IV Esopha...	pralatrexate docetaxel fludeoxyglucose... positron emissi...	18 Years -	Ohio State University Comprehensive Cancer Center
Panitumumab, Paclitaxel, Carboplatin and 5FU in the Treatment of Potentially Resectable Gastroesophageal Adenocarcinoma	NCT01182610	Gastroesophagea... Adenocarcinoma ... Adenocarcinomas... Adenocarcinoma ...	Panitumumab Paclitaxel Carboplatin 5FU	18 Years -	Accelerated Community Oncology Research Network
Pralatrexate and Docetaxel in Treating Patients With Stage IV Esophageal or Gastroesophageal Cancer Who Have Failed Platinum-Based Therapy	NCT01129206	Adenocarcinoma ... Adenocarcinomas... Recurrent Esoph... Squamous Cell C... Stage IV Esopha...	pralatrexate docetaxel fludeoxyglucose... positron emissi...	18 Years -	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for adenocarcinomas of the gastroesophageal junction