Status and phase
Conditions
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About
This phase II trial studies how well combination chemotherapy works in treating patients with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Biopsy-proven and inoperable locally advanced, recurrent, or metastatic cancer of the esophagus, stomach, or gastro-esophageal junction.
Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥10 mm with CT scan, as ≥20 mm by chest x-ray, or ≥10 mm with calipers by clinical exam.
Prior single modality radiation therapy is allowed.
At least 18 years of age.
ECOG performance status ≤ 2
Normal bone marrow and organ function as defined below:
Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Ability to understand and willingness to sign an IRB approved written informed consent document (legally authorized representative is allowed).
Patients already receiving treatment with FOLFIRINOX +/- trastuzumab may participate in the study and have their data collected retrospectively if they met inclusion criteria at the start of therapy and sign consent for study participation moving forward.
Exclusion criteria
Inclusion of Women and Minorities
Both men and women and members of all races and ethnic groups are eligible for this trial.
Primary purpose
Allocation
Interventional model
Masking
67 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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