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Phase II Trial of Gleevec (Imatinib Mesylate) and Taxotere (Docetaxel) as a Combined Regimen for Advanced Gastric Adenocarcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Adenocarcinoma

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Trial Information

Phase II Trial of Gleevec (Imatinib Mesylate) and Taxotere (Docetaxel) as a Combined Regimen for Advanced Gastric Adenocarcinoma


The purpose of this trial is to test the combination of Gleevec® (also known as imatinib
mesylate) and Taxotere (also known as docetaxel) in patients with incurable stomach cancer.
Gleevec is a pill form of chemotherapy and is indicated for the treatment of adult patients
with chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It is
considered experimental for the treatment of stomach cancer. Taxotere (docetaxel) is a
chemotherapy which is injected into the vein. It is approved for breast and lung cancer but
has been shown to shrink many different types of tumors. Taxotere has been shown to shrink
stomach cancer in about 20% - 30% of patients treated with Taxotere only. This study is
being performed to see if the combination of Gleevec and Taxotere is an effective treatment
for incurable stomach cancer with minimal side effects.

Treatment on this study consists of two drugs, Gleevec® and Taxotere. Patients will be
take four tablets of Gleevec® daily throughout the study. After one week of Gleevec®,
patients will then begin receiving doses of Taxotere intravenously once a week for two weeks
in a row followed by one week without Taxotere.


Inclusion Criteria:



- This study is for patients with histologically confirmed unresectable gastric
adenocarcinoma and who have not received any chemotherapy other than 5-FU for
adjuvant therapy either alone or in conjunction with radiation.

Exclusion Criteria:

- Patients may not have received any chemotherapy agents other than 5-FU.

- Patients may not have received 5-FU for for therapy for metastatic gastric cancer.

- Patients must be more than 5 years free of another primary malignancy except: if
other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ.
Existence of any other malignant disease is not allowed.

- Patients must not have Grade III/IV cardiac problems, or any severe and/or
uncontrolled medical disease (i.e. uncontrolled diabetes, chronic renal disease, or
active uncontrolled infection).

- Patient must not have had previously received radiotherapy to >/= 25% of the bone
marrow, or have had major surgery within 2 weeks prior to study entry

- Final eligibility for a clinical trial is determined by the health professionals
conducting the trial.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine if combination of Gleevec and Taxotere is effective treatment for incurable stomach cancer.

Outcome Time Frame:

3 months

Safety Issue:

Yes

Principal Investigator

John Kauh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

0804-2004

NCT ID:

NCT00209079

Start Date:

September 2004

Completion Date:

April 2007

Related Keywords:

  • Gastric Adenocarcinoma
  • Gastric Adenocarcinoma
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322