Esophageal Cancer
Conditions
Keywords
Esophageal Cancer
Brief summary
Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001
Detailed description
32 patients with esophageal or gastroesophageal junction cancer will receive Radiation:50.4 Gy at 180cGy fraction/day for 28 treatments and Paclitaxel Poliglumex (PPX) and Cisplatin weekly times 6 followed by surgery.
Interventions
DRUGPPX with cisplatin and radiation
weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks
Sponsors
University of Maryland Greenebaum Cancer Center
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients are required to have pathologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal junction * Patients may have celiac adenopathy * There must be no evidence of distant organ metastases * No prior chemotherapy or radiation for esophageal cancer * Patients must be \> 18 years of age, and non pregnant * Patients must have an ANC \> 1,500/ul, platelets \> 100,000/ul, creatinine \< 2.0 and bilirubin \< 1.5 x ULN-ECOG performance status 0-1. * Female patients, must either be not of child bearing potential or have a negative pregnancy test within 14 days of starting study treatment. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal. Pregnant or lactating females are not eligible * No contraindications to esophagectomy * Signed informed consent
Exclusion criteria
* Active or uncontrolled infection * Patients must not have other coexistent medical condition that would preclude protocol therapy. * Any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Pathologic Response | At Surgery approximately 4weeks after last treatment | Per pathology review post surgery |
Countries
United States
Participant flow
Recruitment details
Accrual closed in August 2009, 40 patients were enrolled
Participants by arm
| Arm | Count |
|---|---|
| PPX, Cisplatin, Radiation * PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.
* Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | PPX, Cisplatin, Radiation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 40 |
| serious Total, serious adverse events | 14 / 40 |
Outcome results
Primary
Complete Pathologic Response
Per pathology review post surgery
Time frame: At Surgery approximately 4weeks after last treatment
Population: Twelve of 37 patients (32%) had pathologic complete responses. The 12 patients with pathologic CR all had adenocarcinoma.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PPX, Cisplatin, Radiation | Complete Pathologic Response | 12 participants |