Phase II Trial of Gleevec and Taxotere as a Combined Regimen for Advanced Gastric Adenocarcinoma

NCT00209079 | Terminated Phase 2 DMC

• 1 other identifier: 0804-2004
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Gastric Adenocarcinoma

Keywords

Gastric Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

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

  3 months

Secondary Outcomes (1)

• Determine toxicity of combination of Gleevec and Taxotere.

  1 month

Study Arms (1)

1

ACTIVE COMPARATOR

Drug: Gleevec, Taxotere

Interventions

Gleevec, Taxotere DRUG

Gleevec taken 4 times daily, 100 mg per tablet. Taxotere intravenously once a week for two weeks.

Also known as: Imatinib, Mesylate, Docetaxel

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Novartis: collaborator

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Imatinib Mesylate; Docetaxel; Mesylates

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• John Kauh, MD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: September 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: December 31, 2007

Record last verified: 2007-09

Locations

US (1)