Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01129206
Other study ID # OSU-10018
Secondary ID NCI-2010-01225
Status Completed
Phase Phase 2
First received May 21, 2010
Last updated September 15, 2015
Start date July 2010

Study information

Verified date September 2015
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 (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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
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.
Radiation:
fludeoxyglucose F 18
Correlative studies
Procedure:
positron emission tomography
Correlative studies

Locations

Country Name City State
United States Ohio State University Columbus Ohio

Sponsors (3)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center National Comprehensive Cancer Network, Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Response Response was determined using RECIST criteria Approximately three years No
Secondary Progression-free Survival (PFS) PFS was calculated from the date of start of therapy to disease progression or death, whichever occured first. Approximately three years No
Secondary Overall Survival (OS) OS was determined from the date of start of therapy to death frm any cause. Approximately five years No
Secondary Correlation of FDG PET Response With Response Rate 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. Approximately three years No
See also
  Status Clinical Trial Phase
Terminated NCT01705340 - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery Phase 1
Terminated NCT01249443 - Paclitaxel and Carboplatin in Treating Patients With Metastatic or Recurrent Solid Tumors and HIV Infection Phase 1
Completed NCT01612546 - Pilot Trial of CRLX101 in Treatment of Patients With Advanced or Metastatic Stomach, Gastroesophageal, or Esophageal Cancer That Cannot be Removed by Surgery Phase 2
Withdrawn NCT02344810 - C-Met Inhibitor AMG 337, Oxaliplatin, Leucovorin Calcium, and Fluorouracil in Treating Patients With Advanced Stomach or Esophageal Cancer Phase 1/Phase 2
Completed NCT01522820 - Vaccine Therapy With or Without Sirolimus in Treating Patients With NY-ESO-1 Expressing Solid Tumors Phase 1
Terminated NCT00061958 - Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction Phase 2
Terminated NCT00064259 - A Phase I/II Study of Oblimersen Plus Cisplatin and Fluorouracil in Gastric & Esophageal Junction Cancer Phase 1/Phase 2
Completed NCT00045526 - Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer Phase 2
Not yet recruiting NCT05856500 - A Study of Creatine Combined With Curcumin in the Intervention of Early Cachexia in Upper Gastrointestinal Tumors N/A
Active, not recruiting NCT04670445 - Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced Cancer N/A
Completed NCT00607594 - Saracatinib in Treating Patients With Locally Advanced or Metastatic Stomach or Gastroesophageal Junction Cancer Phase 2
Completed NCT00397384 - Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer Phase 1
Completed NCT00077545 - 3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction Phase 2
Completed NCT01231399 - Everolimus and Combination Chemotherapy in Treating Patients With Metastatic Stomach or Esophageal Cancer Phase 1/Phase 2
Completed NCT00031681 - 7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007) Phase 1
Completed NCT00030498 - Erlotinib in Treating Patients With Solid Tumors and Liver or Kidney Dysfunction Phase 1
Active, not recruiting NCT03154190 - Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer N/A
Completed NCT00004074 - Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu Phase 1

External Links