Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma

NCT01757171 | Completed Phase 2 Results DMC

• 1 other identifier: 1208012946
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 5

Brief Summary

Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard administration dose and schedule. This application is a non-labeled indication for cabazitaxel and will inform future drug development in gastroesophageal malignancies, where docetaxel remains an approved first line agent, but is not routinely used due to excessive toxicity and marginal efficacy. At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel in refractory gastric cancer, with preferential activity in one or more gastric cancer subtypes

Conditions

Gastric Adenocarcinoma; Gastroesophageal Adenocarcinoma; Distal Esophageal Adenocarcinoma

Keywords

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Progression at the 3 Month Follow up Visit

  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 Results below list the number of participants who progressed at the 3 month follow up visit

  3 months

Secondary Outcomes (3)

• Duration of Event Free Survival of Subjects Treated With Cabazitaxel

  From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months

• Number of Participants With Response to Cabazitaxel Across Gastric Cancer Subtypes

  From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months

• Percent of Participants Treated With Cabazitaxel With Event Free Survival

  From date of first subject treated until the date of last subject documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Study Arms (2)

Arm A (taxane naïve)

EXPERIMENTAL

No prior Taxane treatment. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks

Drug: Cabazitaxel

Arm B (prior taxane therapy)

EXPERIMENTAL

Subject previously treated with taxane. Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks

Drug: Cabazitaxel

Interventions

Cabazitaxel DRUG

20mg IV over 1 hour every 3 weeks

Arm A (taxane naïve); Arm B (prior taxane therapy)

Eligibility Criteria

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

You may qualify if:

• Subject must have histologically or cytologically confirmed gastric, or gastroesophageal adenocarcinoma, or distal esophageal adenocarcinoma.
• Subject must have unresectable or metastatic gastroesophageal adenocarcinoma.
• Subject must have evaluable disease as per RECIST criteria.
• Subject must have had at least one prior cytotoxic chemotherapy regimen for unresectable or metastatic disease. Prior taxane therapy is allowed.
• Age \>/=18 years old.
• ECOG performance status status \>/= 2
• Subject must have normal organ and marrow function as defined below:
• WBC \>/= 3,000/uL
• Total Bilirubin ≤ 1.5 x upper limits of normal
• AST (SGOT) ≤ 2.5 x upper limits of normal
• ALT (SGPT) ≤ 2.5 x upper limits of normal
• Hgb \> 7.5 g/dl (without transfusion within 7 days)
• ANC \> 1000 /ml
• Plt \> 75 K/ml (without transfusion)
• Creatinine\* \< 2.0 g/dl \*or a calculated creatinine clearance \> 45/cc (using Cockroft-Gault formula)

You may not qualify if:

• Subject with previously untreated unresectable or metastatic gastroesophageal adenocarcinoma.
• Subject with more than 2 prior cytotoxic therapies (not including treatment administered for locally curable disease) for unresectable or metastatic gastroesophageal adenocarcinoma.
• Subject with CNS metastases with active neurologic dysfunction. These patients are excluded because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse event.
• Significant medical co-morbidity that would preclude safe administration of cytotoxic therapy, including but not limited to:
• a.Cardiac disease i. Unstable angina ii. Myocardial infarction \< 3 months prior to study initiation b. Ongoing serious infection i. Bacteremia or sepsis requiring intravenous antibiotics ii. HIV with AIDS defining illness c.Inadequate oral nutritional intake i. Requirement for daily intravenous fluids or total parenteral nutrition. d. Psychiatric illness/social situations that would limit compliance with study requirement
• Subject who has had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from prior treatment related toxicity with persistent symptoms \>/= grade 2 due to agents administered more than 4 weeks earlier.
• Subject may not receive another investigational agent.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cabazitaxel, or to drugs formulated with polysorbate 80.
• Pregnant (positive pregnancy test) and lactating women are excluded from the study because the risks to an unborn fetus or potential risks in nursing infants are unknown.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Sanofi: collaborator

Study Sites (5)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

cabazitaxel

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Results Point of Contact

• Title: Navjot Kaur, GI Program Manager
• Organization: Weill Cornell Medical College

nak2028@med.cornell.edu

646-962-9350

Study Officials

• Manish Shah, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 28, 2012
• Study Start: December 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: June 1, 2017
• Last Updated: April 3, 2018
• Results First Posted: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)