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

NCT01365130 | Terminated Phase 2 Results DMC

• 1 other identifier: BrUOG 243
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Esophageal; Gastrooesophageal Cancer; Gastric Cancer

Keywords

esophageal cancer; gastroesophageal cancer; gastric cancer

Outcome Measures

Primary Outcomes (1)

• Number of Patients Without Progression at 3 Months

  Response will be assessed via RECIST 1.1 criteria

  every three cycles approx every 63 days

Secondary Outcomes (1)

• Number of Patients Experienced a Toxicity Associated With Cabazitaxel for Patients With Metastatic Gastroesophageal Adenocarcinomas That Have Progressed After at Least One Line of Therapy for Metastatic Disease.

  During treatment and through 30 days post treatment, approximately 7 months

Study Arms (1)

real drug

EXPERIMENTAL

patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity

Drug: jevtana

Interventions

jevtana DRUG

Cabazitaxel 25mg/m2, IV every 21 days until progression

Also known as: Cabazitaxel

real drug

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• howard safran: lead
• Roger Williams Medical Center: collaborator
• Rhode Island Hospital: collaborator
• The Miriam Hospital: collaborator

Study Sites (3)

Memorial Hospital

Pawtucket, Rhode Island, 02860, United States

Location

Brown University Oncology Research Group

Providence, Rhode Island, 02903, United States

Location

Roger Williams

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Results Point of Contact

• Title: Howard Safran, MD
• Organization: BrUOG

Hsafran@lifespan.org

4018633000

Study Officials

• Howard safran, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Priniciple Investigator

Study Record Dates

• First Submitted: May 11, 2011
• First Posted: June 3, 2011
• Study Start: June 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: August 1, 2013
• Last Updated: April 12, 2019
• Results First Posted: April 28, 2014

Record last verified: 2019-04

Locations

US (3)