Study of PEP02, Irinotecan or Docetaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00813072
• Date of registration: 18/12/2008
• Prospective Registration: No
• Primary sponsor: PharmaEngine
• Public title: Study of PEP02, Irinotecan or Docetaxel in Gastric or Gastroesophageal Junction Adenocarcinoma
• Scientific title: 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
• Date of first enrolment: November 2007
• Target sample size: 135
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00813072
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Bosnia and Herzegovina, Croatia, Korea, Republic of, Spain, Taiwan, United Kingdom

Contacts

• Name: David Cunningham
• Affiliation: The Royal Marsden Hospital, London & Surrey, UK

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Stomach Neoplasms

Esophageal Neoplasms

Intervention(s)

Drug: PEP02

Drug: irinotecan

Drug: docetaxel

Primary Outcome(s)

objective tumor response [Time Frame: No]

Secondary Outcome(s)

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 [Time Frame: No]

Secondary ID(s)

PEP0206

EudraCT number: 2006-006452-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors