Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00183872
First received: September 9, 2005
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

This study is for people with advanced gastric or gastroesophageal cancer. This study is being done to find out how long it takes tumors to grow after receiving treatment with the drugs irinotecan (also known as CPT-11) and docetaxel (also known as Taxotere). Irinotecan is a drug that has been approved by the Food and Drug Administration (FDA). Irinotecan has been approved for treatment of cancer of the colon and rectum. Docetaxel is another drug approved by the FDA. Docetaxel is approved for treatment of breast, prostate and lung cancer. However, the FDA has authorized the use of irinotecan and docetaxel in this study. This study will evaluate the effects of these drugs on participant's tumors. The side effects of the combination of irinotecan and docetaxel will also be evaluated. This study will also measure the levels of certain substances in participant's tumors. These substances, called genes (which are the cell's blueprint), affect how people's bodies react to the cancer drugs. Genes will also be measured in participant's blood. The researchers want to see if these substances can predict response to the study drugs.


Condition Intervention Phase
Gastric Cancer
Esophageal Neoplasms
Drug: irinotecan, docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • To assess the response rate of patients with metastatic or unresectable adenocarcinoma of the stomach or gastroesophageal junction treated with the combination of irinotecan and docetaxel as second line therapy [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess progression free survival rate and overall survival in these patients [ Time Frame: every 2 cycles ] [ Designated as safety issue: No ]
  • To assess the toxicity of this regimen [ Time Frame: day 1 and 8 each cycle ] [ Designated as safety issue: Yes ]
  • To identify molecular correlates of response and survival (gene expression and genomic polymorphisms of enzymes involved in drug metabolism, DNA repair and apoptosis) [ Time Frame: bsl and end of treatment ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: April 2005
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - Irinotecan and Docetaxel
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
Drug: irinotecan, docetaxel
docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have clinically documented unresectable or metastatic gastric cancer or gastroesophageal adenocarcinoma and histologic confirmation of the diagnosis with tumor.
  • Patients must have received one prior chemotherapeutic regimen for metastatic or unresectable disease. Patients may not have received prior therapy with irinotecan or a taxane.
  • Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection or if it is not available, a repeat biopsy must be performed.
  • Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.
  • Patients must have measurable disease by clinical exam or radiologic studies, that is at least one lesion measurable in at least one dimension, measuring 10 mm or more on a spiral CT scan, or at least 20 mm by an exam or a non-spiral scan. If prior radiation therapy was administered, measurable disease must be outside the radiation field.
  • Patients must have a Zubrod performance status of 0-2.
  • Patients must have a predicted life expectancy of at least 12 weeks.
  • Patients must have:

    • a pre-treatment granulocyte count (i.e., segmented neutrophils + bands) of >1,500/mm3,
    • a hemoglobin level of greater than or equal to 9.0 gm/dl, and
    • a platelet count of >100,000/mm3.
  • Patients must have adequate renal function as documented by a calculated creatinine clearance > 60.
  • Patients must have adequate hepatic function as documented by a serum bilirubin less than or equal to the institutional upper limit of normal, regardless of whether patients have liver involvement secondary to tumor.
  • No major surgery within 1 month of starting study drug.
  • Women of childbearing potential must have a negative pregnancy test.
  • Peripheral neuropathy: must be < grade 1

Exclusion Criteria:

  • Patients may not have a history of an allergy to irinotecan.
  • Patients with any active or uncontrolled infection, including known HIV infection.
  • Patients with psychiatric disorders that would interfere with consent or follow-up.
  • Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy.
  • Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on treatment and for at least 3 months thereafter.
  • Presence of clinically apparent central nervous system metastases or carcinomatous meningitis.
  • Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible.
  • Patients with any other severe concurrent disease, which in the judgment of the investigator would make the patient inappropriate for entry into this study.
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183872

Locations
United States, California
University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Sanofi
Investigators
Principal Investigator: Syma Iqbal, M.D. University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00183872     History of Changes
Other Study ID Numbers: 3G-03-5
Study First Received: September 9, 2005
Last Updated: May 20, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Gastroesophageal cancer
Gastric Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Docetaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014