Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA) in Metastatic Esophageal and Gastric Cancer

NCT00394433 | Completed Phase 2 Results DMC

• 1 other identifier: 06-100
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this research study is to determine if the combination of docetaxel, cisplatin, irinotecan and bevacizumab will help shrink metastatic esophageal or gastric cancer and how the cancer responds to this combination. Bevacizumab is a new drug that is believed to stop the formation of new blood vessels that carry nutrients to tumors. Bevacizumab is approved for use in metastatic colon and rectal cancer. Docetaxel, cisplatin and irinotecan are traditional chemotherapy agents that have been tested together in another clinical trial for esophageal and gastric cancer. It is hoped that adding bevacizumab to this regimen will make the treatment more effective.

Conditions

Esophageal Cancer; Stomach Cancer

Keywords

TPCA; Taxotere; Platinum; Avastin; Camptosar; gastric cancer

Outcome Measures

Primary Outcomes (1)

• 10-month Progression-Free Survival Rate

  10-month progression-free survival rate is the probability of patients remaining alive and progression-free at 10-months from study entry estimated using Kaplan-Meier methods. Per RECIST 1.0 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

  Disease was evaluated radiologically at baseline and every 2 cycles on treatment; Treatment continued until disease progression or unacceptable toxicity. Relevant for this endpoint was disease status at 10 months.

Secondary Outcomes (3)

• Best Response

  Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).

• Overall Survival

  Patients in the study cohort were followed for a median of 12.2 month (up to 40 months).

• Progression-Free Survival

  Disease was evaluated radiologically at baseline and every 2 cycles on treatment. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 6 cycles/18 weeks given 3-week cycle length (range 1-26 cycles).

Study Arms (1)

Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)

EXPERIMENTAL

Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.

Drug: Bevacizumab; Drug: Docetaxel; Drug: Cisplatin; Drug: Irinotecan

Interventions

Bevacizumab DRUG

Also known as: Avastin

Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)

Docetaxel DRUG

Also known as: Taxotere, Docefrez

Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)

Cisplatin DRUG

Also known as: Platinol-AQ, Platinol

Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)

Irinotecan DRUG

Also known as: Camptosar

Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed, unresectable esophageal or gastric carcinoma (carcinoma=adenocarcinoma or squamous cell carcinoma)
• Measurable disease greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan or 2 cm or greater by other radiographic technique
• Lesions must be measurable in at least one dimension
• Bone lesions, ascites, and effusions are not measurable
• years of age or older
• ECOG performance status 0 or 1
• Life expectancy of at least 12 weeks
• Adequate bone marrow function
• Adequate renal function
• Adequate liver function

You may not qualify if:

• Prior chemotherapy (except as part of pre- or post-operative therapy, completed more than 1 year prior to start day of this protocol)
• History of severe hypersensitivity to bevacizumab, docetaxel, cisplatin, irinotecan, or drugs formulated with polysorbate 80
• Current, recent (within 4 weeks) or planned participation in an experimental drug study
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study
• Minor surgical procedures, such as fine needle aspirations, port-a-cath placement, or core biopsies within 7 days prior to Day 0 of study
• Myocardial infarction or stroke in past 6 months
• Blood pressure of \> 150/100 mmHg
• Unstable angina
• New York Heart Association (NYHA) grade II or greater congestive heart failure
• Clinically significant peripheral vascular disease
• Persistent bleeding from primary tumor, while off anticoagulants, requiring repeated transfusions
• Evidence of bleeding diathesis or coagulopathy
• Uncontrolled serious medical or psychiatric illness
• Uncontrolled diarrhea
• Peripheral neuropathy \> grade 1

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Massachusetts General Hospital: collaborator
• Genentech, Inc.: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Interventions

Bevacizumab; Docetaxel; Cisplatin; Irinotecan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Camptothecin; Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Peter C. Enzinger, MD
• Organization: Dana-Farber Cancer Institute

Peter_Enzinger@dfci.harvard.edu

617-632-6855

Study Officials

• Peter Enzinger, MD

  Dana-Farber Cancer Institute

  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: PRINCIPAL INVESTIGATOR
• PI Title: Overall PI

Study Record Dates

• First Submitted: October 31, 2006
• First Posted: November 1, 2006
• Study Start: September 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: October 1, 2016
• Last Updated: August 1, 2017
• Results First Posted: January 16, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)