Phase 2
N=29
Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
Esophageal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00448760 ↗Enrolled (actual)
29
Serious AEs
86.2%
Results posted
Feb 2013
Primary outcome: Primary: Pathologic Complete Response — 16.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Docetaxel (Drug); Floxuridine (Drug); Leucovorin (Drug); Oxaliplatin (Drug); Microarray analysis (Genetic); reverse transcriptase-polymerase chain reaction (Genetic); Conventional surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pathologic Complete Response |
16.7 | — |
| SECONDARY Clinical Response |
72.4 | — |
| SECONDARY Median Progression-free Survival (PFS) |
13.6 | — |
| SECONDARY Overall Survival |
21.4 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and leucovorin, 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. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with previously untreated stage II or stage III esophageal cancer that can be removed by surgery.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of adenocarcinoma of the esophagus meeting the following criteria:
- Stage II or III disease
- Resectable disease
- Previously untreated disease
- No stage I (mucosal only) or stage IV (metastatic) disease
PATIENT CHARACTERISTICS:
- WBC > 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Creatinine ≤ 2.0 mg/dL
- Bilirubin < 2 times normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have central venous access
- No other malignancy within the past 5 years
- No concurrent medical or psychiatric problem that would preclude study treatment
- No contraindications to paclitaxel
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy to the esophagus
- No oral cryotherapy (e.g., ice chips) on day 1 of each course
Data sourced from ClinicalTrials.gov (NCT00448760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.