Status:
COMPLETED
Study of PEP02, Irinotecan or Docetaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
Lead Sponsor:
PharmaEngine
Conditions:
Stomach Neoplasms
Esophageal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess objective tumor response in the single agent treatment of PEP02, irinotecan, or docetaxel for locally advanced or metastatic gastric or gastroesophageal junction...
Detailed Description
Palliative chemotherapy has been shown to improve survival compared with best supportive care alone in patients with unresectable or recurrent gastric cancer. There is no standard second-line chemothe...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of gastric or gastroesophageal junction
- Failed to only one systemic chemotherapy for locally advanced or metastatic disease, including patients whose diseases recur within 6 months after (neo)adjuvant chemotherapy. Chemotherapy administered with concurrent radiotherapy is NOT considered as systemic chemotherapy.
- Have at least one measurable lesion according to the RECIST criteria
- Aged above or equal to 18 years, at the time of acquisition of informed consent
- With ECOG performance status 0, 1, or 2
- Life expectancy equal to or more than 3 months
- With adequate organ and marrow function as defined below:
- With ability to understand and the willingness to sign a written Informed Consent Form
Exclusion
- Had systemic chemotherapy within 3 weeks before the commencement of study treatment
- Had radiotherapy within 4 weeks before the commencement of study treatment
- With known brain metastasis
- With active multiple cancers or had treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer
- With prior irinotecan or taxane (paclitaxel, docetaxel) treatment
- Have received irradiation affecting \> 30% of the active bone marrow
- Had major surgery within 4 weeks of the start of study treatment (laparotomy, line placement is not considered major surgery)
- Have not recovered from prior treatments
- With preexisting peripheral neuropathy \> grade 2
- With history of allergic reaction to liposome product or other drugs formulated with polysorbate
- With uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, active gastrointestinal bleeding, watery stools, central nervous system disorders or psychiatric illness/social situation that would limit compliance with study requirements or judged to be ineligible for the study by the investigator
- Have received any investigational agents within 3 weeks preceding the start of study treatment
- Pregnant or breastfeeding females (a pregnancy test must be performed on all female patients who are of child-bearing potential before entering the study, and the result must be negative)
- With intestinal obstruction
- Have received St. John's Wort, CYP3A4 inducing anticonvulsants (phenytoin, phenobarbital, and carbamazepine), rifampin and rifabutin within two weeks, or ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem and verapamil within one week before the administration of study medications
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT00813072
Start Date
November 1 2007
End Date
December 1 2010
Last Update
March 2 2012
Active Locations (22)
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1
Clinical Hospital Mostar
Mostar, Bosnia and Herzegovina, 36 000
2
Clinical Centre University of Sarajevo
Sarajevo, Bosnia and Herzegovina, 71 000
3
University Hospital Centre Rijeka
Rijeka, Croatia, 51 000
4
University Hospital Centre Dubrava
Zagreb, Croatia, 10 000