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Chemotherapy for Patients With Gastroesophageal Cancers Who Have Progressed After One Prior Chemo Regimen

This study has been terminated.
(As of 12/12/12 study closed to enrollment because study was determined to be ineffective.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365130
First Posted: June 3, 2011
Last Update Posted: June 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Roger Williams Medical Center
Rhode Island Hospital
The Miriam Hospital
Information provided by (Responsible Party):
howard safran, Brown University
  Purpose
The purpose of this study is to evaluate the effectiveness of Cabazitaxel, as well as safety and side effects for patients with advanced gastroesophageal cancer

Condition Intervention Phase
Esophageal Gastrooesophageal Cancer Gastric Cancer Drug: jevtana Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Of Cabazitaxel For Metastatic Gastroesophageal Adenocarcinomas That Have Relapsed After At Least One Line Of Chemotherapy

Resource links provided by NLM:


Further study details as provided by howard safran, Brown University:

Primary Outcome Measures:
  • Number of Patients Without Progression at 3 Months [ Time Frame: every three cycles approx every 63 days ]
    Response will be assessed via RECIST 1.1 criteria


Secondary Outcome Measures:
  • To Assess the Toxicity Associated With Cabazitaxel for Patients With Metastatic Gastroesophageal Adenocarcinomas That Have Progressed After at Least One Line of Therapy for Metastatic Disease. [ Time Frame: at approx 6, 12 and 18 months ]
    We will look at the number of patients who have Hematologic Toxicity as well as non-hematologic toxicity


Enrollment: 15
Study Start Date: June 2011
Study Completion Date: August 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: real drug
patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity
Drug: jevtana
Cabazitaxel 25mg/m2, IV every 21 days until progression
Other Name: Cabazitaxel

Detailed Description:

Gastric cancer is the second most frequent cancer-related cause of death after lung cancer worldwide with approximately 900,000 cases per year. The incidence of gastric cancer is highest in East Asia, China and Japan. In the last two decades there has been a dramatic increase in North America and Europe of adenocarcinoma of the distal esophagus and GE junction which are indistinguishable from proximal gastric cancer.

Cabazitaxel (XRP6258) is a semi-synthetic novel taxoid. Like traditional taxane drugs, it binds to and stabilizes tubilin structures resulting in inhibition of cold-induced microtubule depolymerization and cell division with subsequent inhibition of tumor cell proliferation. This novel agent, however, has poor affinity for P-glycoprotein--the protein product of multidrug resistance gene ABCB1. P-glycoprotein is a membrane-associated drug efflux pump and is thought to be a potential cause of taxane resistance in tumors. Also unlike traditional taxanes, Cabazitaxel has exhibited penetration through the blood-brain barrier (BBB.) Preclinical studies have demonstrated that Cabazitaxel was cytotoxic for cell lines with acquired resistance to doxorubicin, vincristine, vinblastine, paclitaxel or docetaxel.

Taxanes have demonstrated statistically significant antitumor activity as both monotherapy and as part of combination triplet regimens in gastroesophageal carcinoma.Cabazitaxel has emerged as a novel investigational semi-synthetic taxoid that has established activity in cell lines refractory to traditional taxanes in preclinical studies and now in a phase III study in patients with metastatic prostate cancer. Cabazitaxel, with its low affinity for the P-glycoprotein drug efflux pump, may demonstrate superior response rates to docetaxel. Furthermore, as demonstrated in prostate cancer, cabazitaxel appears to have substantial activity in patients who have previously been treated with docetaxel.

Phase I and II trials have been conducted demonstrating safety and efficacy of Cabazitaxel (XRP6258) in metastatic breast and prostate cancer. Neutropenia was the primary dose-limiting toxicity with the recommended dose established at 20 and 25mg/m2. The latter dose was used in the TROPIC trial, the pivotal phase III trial demonstrating improved overall survival and median progression free survival in patients with hormone resistant prostate cancer refractory to docetaxel who had received Cabazitaxel plus prednisone versus those who received mitaxantrone plus prednisone. Cabazitaxel given at IV doses of 25mg/m2 has demonstrated both safety and anti-tumor efficacy in phase I, II and now phase III trials

The primary goal is to evaluate the activity of Cabazitaxel for the treatment of advanced gastroesophageal cancer that has progressed after at least one line of treatment for metastatic disease. Activity will be defined as a complete or partial response. The investigators will differentiate between a 10% level of activity and a 30% level of activity.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients are required to have histologically or pathologically confirmed metastatic gastric or esophageal adenocarcinoma.
  • Patients must demonstrate relapse or progression after at least one prior line of chemotherapy for metastatic disease.
  • Patients must have measurable disease by CT scan or MRI
  • Absolute neutrophil count ≥ 1,500/uL, platelet ≥ 100,000/uL and Hgb > 8.0 g/dl.
  • Total bilirubin ≤ upper institutional limit of normal (ULN), and AST or ALT ≤ 3x ULN; if liver metastases then AST or ALT < 5x ULN
  • Peripheral neuropathy must be ≤ Grade 1
  • Creatinine < 2 x ULN
  • ECOG performance status 0 to 2
  • Minimum life expectancy of 12 weeks.
  • Age older than 18 years.
  • Voluntary, signed written informed consent.
  • Women of childbearing potential must have a negative pregnancy test Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.

Exclusion Criteria:

  • History of severe hypersensitivity reaction to Cabazitaxel or other drugs formulated with polysorbate 80.
  • Patients with known, untreated brain metastasis
  • Any uncontrolled severe, intercurrent illness.
  • Women who are breast-feeding.
  • Patients who have undergone major surgery, chemotherapy, or radiotherapy within the last 3 weeks.
  • Patients on concurrent anticancer therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365130


Locations
United States, Rhode Island
Memorial Hospital
Pawtucket, Rhode Island, United States
Brown University Oncology Research Group
Providence, Rhode Island, United States, 02903
Roger Williams
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
howard safran
Roger Williams Medical Center
Rhode Island Hospital
The Miriam Hospital
Investigators
Principal Investigator: Howard safran, MD Brown University
  More Information

Additional Information:
Responsible Party: howard safran, Priniciple Investigator, Brown University
ClinicalTrials.gov Identifier: NCT01365130     History of Changes
Other Study ID Numbers: BrUOG 243
First Submitted: May 11, 2011
First Posted: June 3, 2011
Results First Submitted: February 20, 2014
Results First Posted: April 28, 2014
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by howard safran, Brown University:
esophageal cancer
gastroesophageal cancer
gastric cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases