Study of PEP02, Irinotecan or Docetaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
A Randomized Phase II Study of PEP02, Irinotecan or Docetaxel as a Second Line Therapy in Patients With Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
2 other identifiers
interventional
135
6 countries
22
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 adenocarcinoma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2007
Typical duration for phase_2
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 18, 2008
CompletedFirst Posted
Study publicly available on registry
December 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMarch 2, 2012
March 1, 2012
2.7 years
December 18, 2008
March 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
objective tumor response
Secondary Outcomes (1)
progression-free survival, duration of tumor response, time to progression, time to treatment failure, disease control rate, 1-year survival rate,and overall survival; pharmacokinetics and pharmacogenetics of PEP02 and irinotecan
Study Arms (3)
1. PEP02
EXPERIMENTALliposome irinotecan
2. irinotecan
ACTIVE COMPARATOR3. docetaxel
ACTIVE COMPARATORInterventions
120 mg/m2, IV infusion for 90 minutes on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
300 mg/m2, IV infusion on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
75 mg/m2, IV infusion for 60 minutes on day 1 of each 21 day as a treatment cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PharmaEnginelead
Study Sites (22)
Clinical Hospital Mostar
Mostar, 36 000, Bosnia and Herzegovina
Clinical Centre University of Sarajevo
Sarajevo, 71 000, Bosnia and Herzegovina
University Hospital Centre Rijeka
Rijeka, 51 000, Croatia
University Hospital Centre Dubrava
Zagreb, 10 000, Croatia
University Hospital Centre Zagreb
Zagreb, 10 000, Croatia
Samsung Medical Center
Seoul, 135-710, South Korea
Asan Medical Center
Seoul, 138-736, South Korea
National Cancer Center
Seoul, 410-769, South Korea
Hospital Universitario Vall d'Hebron
Barcelona, 08035, Spain
Hospital General Universitario de Elche
Elche, 03203, Spain
Hospital ClĂnico San Carlos
Madrid, 28040, Spain
Hospital Universitario Marques de Valdecilla
Santander, 39008, Spain
Chang Gung Memorial Hospital - Chiayi
Chiayi City, Taiwan
Chang Gung Memorial Hospital - LinKou
Linkou District, Taiwan
National Cheng Kung University Hospital
Tainan, 704, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Mackay Memorial Hospital
Taipei, 25115, Taiwan
Addenbrookes Hospital Oncology Center
Cambridge, CB2 2QQ, United Kingdom
Guy's & St Thomas' NHS Foundation Trust
London, SE19RT, United Kingdom
Kent Oncology Centre, Maidstone Hospital
Maidstone, ME16 9QQ, United Kingdom
Southampton University Hospital
Southampton, SO16 6YD, United Kingdom
The Royal Marsden Hospital
Surrey, SM2 5PT, United Kingdom
Related Publications (1)
Roy AC, Park SR, Cunningham D, Kang YK, Chao Y, Chen LT, Rees C, Lim HY, Tabernero J, Ramos FJ, Kujundzic M, Cardic MB, Yeh CG, de Gramont A. A randomized phase II study of PEP02 (MM-398), irinotecan or docetaxel as a second-line therapy in patients with locally advanced or metastatic gastric or gastro-oesophageal junction adenocarcinoma. Ann Oncol. 2013 Jun;24(6):1567-73. doi: 10.1093/annonc/mdt002. Epub 2013 Feb 13.
PMID: 23406728DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Cunningham
The Royal Marsden Hospital, London & Surrey, UK
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2008
First Posted
December 22, 2008
Study Start
November 1, 2007
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
March 2, 2012
Record last verified: 2012-03