Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Cancer, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2005 |
| End Date: | June 2017 |
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.
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.
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.
We found this trial at
1
site
Los Angeles, California 90033
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