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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

Phase 3
18 Years
Open (Enrolling)
Advanced Gastric Cancer, Esophagogastric Junction Cancer

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Trial Information

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

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 in terms of hazard ratio of progression-free 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 lesions (measurable vs evaluable).

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

6 months follow-up

Safety Issue:


Principal Investigator

Salah-Eddin Al-Batran, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Krankenhaus Nordwest


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

October 2011

Completion Date:

January 2016

Related Keywords:

  • Advanced Gastric Cancer
  • Esophagogastric Junction Cancer
  • RAD001
  • Paclitaxel
  • gastric cancer
  • advanced gastric or esophagogastric junction cancer
  • Carcinoma
  • Stomach Neoplasms