Neoadjuvant Paclitaxel Poliglumex, Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial (CTI#X64001)

NCT00522795 — Phase 2, Completed, 40 participants, Brown University

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BrUOG-E-215-Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001

Registry	NCT00522795
Status	Completed
Phase	Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	40 (Actual)
Sponsor	Brown University (Other); collaborators: University of Maryland Greenebaum Cancer Center
Conditions	Esophageal Cancer
Interventions	PPX with cisplatin and radiation (Drug)
Dates	start 2007-08-01, primary completion 2010-02-01, completion 2010-04-01, first posted 2007-08-30, last updated 2020-02-17
Locations	1 site in United States

-Summary

Neoadjuvant Paclitaxel Poliglumex (PPX; CT-2103), Cisplatin and Radiation for Esophageal Cancer: A Phase II Trial. (CTI#X64001

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
PPX with cisplatin and radiation	Experimental	Drug: PPX with cisplatin and radiation	PPX 50mg/m2 wk and cisplatin 25mg/m2 wk for 6 weeks with 50.4 GY concurrent radiation

PPX with cisplatin and radiation (Drug), also known as Paclitaxel Poliglumex, Cisplatin and radiation: weekly IV treatment of Paclitaxel Poliglumex and Cisplatin for 6 weeks

+Outcome measures

Primary outcomes

Complete Pathologic Response [At Surgery approximately 4weeks after last treatment]: Per pathology review post surgery

+Eligibility

Sex: All, ages: 19 Years to any

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).

+Posted results

Participant flow

Milestone	PPX, Cisplatin, Radiation
Started	40
Completed	40
Not completed	0

Outcome results

Complete Pathologic Response (Primary), Number, participants: PPX, Cisplatin, Radiation 12

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
PPX, Cisplatin, Radiation	0	14/40 (35.0%)	2/40 (5.0%)

Serious adverse events by term

Term	Organ system	PPX, Cisplatin, Radiation
esophagitis, nauseam dehydration, electrolyte imbalance, potassium and mood alteration	Investigations	1/40
allergic reaction/hypersensitivity	Investigations	1/40
nausea, dehydration, esophagitis, death	Investigations	1/40
multiorgan failure	Investigations	1/40
leukopenia, esophagitis, dehydration, nausea, vomiting, neutropenia, hypotension	Investigations	1/40
hyperglycemia, dehydration	Investigations	1/40
infection of gallbladder with normal ANC	Investigations	1/40
dysphagia, dizziness, dehydration	Investigations	1/40
hypokalemia, hypomagnesemia, weakness, anorexia, opportunistic infection	Investigations	1/40
thrombosis, hematoma, hypomagnesemia, extrapyramidal/restless	Investigations	1/40
nausea, vomiting, weakness, ischemic colitis	Investigations	1/40
thrombosis/embolism	Investigations	1/40
infection with normal ANC (cellulitis) and albumin	Investigations	1/40
pneumothorax	Investigations	1/40
DVT	Investigations	1/40
acute vascular leak, GI other, hypotension, anorexia, hypothermia,INR	Investigations	1/40
abdominal pain and dehydration	Investigations	1/40

Other adverse events by term

Term	Organ system	PPX, Cisplatin, Radiation
esophagitis	Investigations	2/40

+Locations (1)

Facility	City	Country	Status
Lifespan Hospitals	Providence, Rhode Island	United States

+Investigators

Howard Safran, MD, Principal investigator, Brown University