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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01248403
Recruitment Status : Completed
First Posted : November 25, 2010
Last Update Posted : January 29, 2020
Information provided by (Responsible Party):
Prof. Dr. S.E. Al-Batran, Krankenhaus Nordwest

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Gastric Cancer Esophagogastric Junction Cancer Drug: Paclitaxel Drug: RAD001 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : October 2011
Actual Primary Completion Date : July 2017
Actual Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paclitaxel

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:
  • Everolimus
  • Certican

Primary Outcome Measures :
  1. overall survival [ Time Frame: 6 months follow-up ]

Secondary Outcome Measures :
  1. best overall response [ Time Frame: staging every 8 weeks ]
  2. progression-free survival [ Time Frame: staging every 8 weeks ]
  3. number of participants with adverse events as a measure of safety and tolerability [ Time Frame: every week until end of treatment ]
  4. disease control rate [ Time Frame: every 8 weeks ]
    responders + stable disease ≥12 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01248403

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Krankenhaus Nordwest
Frankfurt/Main, Germany, 60488
Sponsors and Collaborators
Krankenhaus Nordwest
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Principal Investigator: Salah-Eddin Al-Batran, MD Institute of Clinical Cancer Research (IKF), UCT - University Cancer Center, Frankfurt, Germany
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. S.E. Al-Batran, Principal Investigator, Krankenhaus Nordwest Identifier: NCT01248403    
Other Study ID Numbers: CRAD001RDE35T
First Posted: November 25, 2010    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No IPD will be shared.
Keywords provided by Prof. Dr. S.E. Al-Batran, Krankenhaus Nordwest:
gastric cancer
advanced gastric or esophagogastric junction cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs