Trials Sponsors Conditions Drugs Pricing

Conditions

Gastric Cancer Esophageal Neoplasms

Keywords

Gastroesophageal cancerGastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

Objective Response (Complete, Partial, Stable and Progression)
Objective response was defined using standard RECIST criteria. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter or target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet criteria of CR, PR, and PD.
every 2 cycles

Secondary Outcomes (1)

Progression Free Survival
every 2 cycles

Study Arms (1)

Arm 1 - Irinotecan and Docetaxel

EXPERIMENTAL

Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days

Drug: irinotecan, docetaxel

Interventions

irinotecan, docetaxelDrug

docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.

Arm 1 - Irinotecan and Docetaxel

Named ingredients in these interventions

Linked from the registry description. Each source intervention is retained as reported.

Docetaxel
In: irinotecan, docetaxel
Irinotecan
In: irinotecan, docetaxel

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
irinotecan, docetaxel
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must have clinically documented unresectable or metastatic gastric cancer or gastroesophageal adenocarcinoma and histologic confirmation of the diagnosis with tumor.
Patients must have received one prior chemotherapeutic regimen for metastatic or unresectable disease. Patients may not have received prior therapy with irinotecan or a taxane.

Sponsors & Collaborators

Sanofi
Industrycollaborator
University of Southern California
Otherlead

Study Sites (1)

University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

MeSH Terms

Conditions

Stomach NeoplasmsEsophageal Neoplasms

Interventions

IrinotecanDocetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesHead and Neck NeoplasmsEsophageal Diseases

Intervention Hierarchy (Ancestors)

Results Point of Contact

Title: Victoria Soto - Project Specialist
Organization: USC/Norris Comprehensive Cancer Center

Study Officials

Syma Iqbal, M.D.
University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: Yes

Enrollment

40 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

April 14, 2005

Actual (reported)

Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Arm 1 - Irinotecan and Docetaxel

Interventions

Named ingredients in these interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Arm 1 - Irinotecan and Docetaxel

Interventions

Named ingredients in these interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations