Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 19 - Any |
Updated: | 3/22/2019 |
Start Date: | August 2007 |
End Date: | April 2010 |
BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001
Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal
Cancer: A Phase II Trial. (CTI#X64001
Cancer: A Phase II Trial. (CTI#X64001
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.
Gy at 180cGy fraction/day for 28 treatments and Paclitaxel Poliglumex (PPX) and Cisplatin
weekly times 6 followed by surgery.
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).
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