A Randomized, Double Blind Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma After Prior Chemotherapy (AIO-STO-0111)

January 27, 2020 updated by: Prof. Dr. S.E. Al-Batran, Krankenhaus Nordwest

A Randomized, Double-blind, Multi-center Phase III Study Evaluating Paclitaxel With and Without RAD001 in Patients With Gastric Carcinoma Who Have Progressed After Therapy With a Fluoropyrimidine-containing Regimen

Adult patients with gastric carcinoma which has progressed after initial treatment with a fluoropyrimidines-containing regimen will be treated with paclitaxel plus RAD001 or plus placebo. The hypothesis is that patients with RAD001 have significantly prolonged overall survival compared to patients who are treated with paclitaxel alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, phase III two-arm multi-center study aiming at estimating the relative efficacy of the combination of RAD001 and paclitaxel versus that of paclitaxel alone as second-, third- or fourth-line treatment in terms of hazard ratio of overall survival in patients with gastric cancer who have relapsed after one treatment regimen containing a fluoropyrimidine (e.g., 5-FU, S-1, capecitabine and other 5-FU prodrugs or derivatives). Patients will be randomized in a 1:1 ratio for a total of 240 patients per treatment arm. Randomization will be stratified according to performance status (0-1 versus 2), prior taxan use (yes vs. no) and treatment line (2nd versus 3rd/4th line).

Study treatment will be continued until progression or intolerable toxicity. Patients will be seen at baseline/screening, and weekly for paclitaxel administration and safety assessment until disease progression or discontinuation of trial therapy for other reasons. Radiological tumor assessment will be performed every second cycle (every 8 weeks) or earlier if clinically indicated. Post-study follow-up will be completed every 8 weeks for survival.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt/Main, Germany, 60488
        • Krankenhaus Nordwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients ≥ 18 years old
  • Histologically or cytologically confirmed and documented gastric adenocarcinoma. Adenocarcinomata of the gastro-esophageal junction will be allowed, if they have advanced disease (inoperable, recurrent or metastatic disease).
  • Documented progressive disease during/after one, two or three prior treatments containing 5FU and/or its precursors or derivatives in the palliative setting
  • At least one measurable or evaluable lesion by RECIST as determined by Computed Tomography (CT) Scan or Magnetic Resonance Imaging (MRI)
  • ECOG performance status of 0, 1 or 2

  • The following laboratory parameters:

    • Absolute neutrophil count ≥ 1.5 x 109/L
    • Platelets ≥ 100 x 109/L
    • Hemoglobin (Hgb) ≥ 9 g/dL
    • Serum creatinine ≤ 2 x Upper Limit of Normal (ULN)
    • Adequate liver function:
    • Total serum calcium (corrected for serum albumin) or ionized calcium ≥ LLN
  • Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study treatments and must be willing to use adequate methods of contraception during the study and for 3 months after last study drug administration.
  • Written informed consent

Exclusion Criteria:

  • Current treatment with any anti cancer therapy or treatment with anti cancer therapy ≤ 2 weeks prior to study treatment start unless rapidly progressing disease is measured
  • Known hypersensitivity to RAD001 (everolimus) or to its excipients, or to other rapamycins (e.g. sirolimus, temsirolimus)
  • Known prior history of hypersensitivity to paclitaxel.
  • Paclitaxel refractory disease, which is defined as a disease progression under or within 12 weeks of last taxan treatment
  • Chronic treatment with steroids (except for oral, topical or local injection) or another immunosuppressive agent
  • Major surgery ≤ 2 weeks prior to starting study treatment or patients who have not recovered from such therapy
  • Lack of resolution of all acute toxic effects (excluding alopecia) of prior chemotherapy, prior radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade <= 1. Note: Neuropathy due to prior chemotherapy is allowed.

  • Unstable CNS disease

    • Requiring increasing doses of steroids to maintain stable neurological status
    • Deteriorating / changing neurological status
  • Known history of HIV seropositivity (HIV testing is not mandatory) or Hepatitis B or C.
  • Active, bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin, as long as the INR is <= 2.0)
  • Any other severe and/or uncontrolled medical conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: paclitaxel + placebo

Paclitaxel 80 mg/m2 on day 1, day 8 and day 15 of every 28-day cycle.

+ Placebo (2 tablets / day) d1-d28
Drug: Paclitaxel
Paclitaxel 80 mg/m2 on day 1, day 8 and day 15 of every 28-day cycle.
Experimental: paclitaxel + RAD001

Paclitaxel 80 mg/m2 on day 1, day 8 and day 15 of every 28-day cycle.

+ RAD001 10mg (2 x5 mg tablets / day) d1-d28
Drug: Paclitaxel
Paclitaxel 80 mg/m2 on day 1, day 8 and day 15 of every 28-day cycle.
Drug: RAD001
RAD001 10mg (2 x5 mg tablets / day) d1-d28
Other Names:
  • Certican
  • Everolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 6 months follow-up
6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
best overall response
Time Frame: staging every 8 weeks
staging every 8 weeks
progression-free survival
Time Frame: staging every 8 weeks
staging every 8 weeks
number of participants with adverse events as a measure of safety and tolerability
Time Frame: every week until end of treatment
every week until end of treatment
disease control rate
Time Frame: every 8 weeks
responders + stable disease ≥12 weeks
every 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krankenhaus Nordwest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2011

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 27, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001RDE35T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No IPD will be shared.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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