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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Cancer; Esophageal Neoplasms
• Intervention / Treatment: Drug: irinotecan, docetaxel

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response (Complete, Partial, Stable and Progression)	Objective response was defined using standard RECIST criteria. CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter or target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet criteria of CR, PR, and PD.	every 2 cycles

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Progression free survival is measured from the start of treatment until the time the participant is first recorded as having disease progression, or death due to any cause. If a participant has not progressed or died, progression free survival is censored at the time of the last follow up.	every 2 cycles

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Sanofi
• Investigators: Principal Investigator: Syma Iqbal, M.D., University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2005
• Primary Completion (Actual): October 20, 2014
• Study Completion (Actual): October 20, 2015

Study Registration Dates

• First Submitted: September 9, 2005
• First Submitted That Met QC Criteria: September 9, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: January 21, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma; Gastroesophageal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Adenocarcinoma; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Docetaxel; Irinotecan
• Other Study ID Numbers: 3G-03-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No