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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

Phase 2
18 Years
Not Enrolling
Stomach Neoplasms, Esophageal Neoplasms

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Trial Information

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

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 chemotherapy for advanced gastric cancer and no randomized-controlled trial data
suggest a benefit of second-line chemotherapy compared with supportive care alone. Response
rates of second-line therapy in phase II trials are similar to those seen for other cancers
that are more commonly retreated. Combination therapy may achieve higher response rates
than single agents, however, the survival outcome are the same. In addition, data suggest
that patients may obtain symptomatic benefits from second-line therapy. In comparison to
the toxicity profile of single agent with combination regimen, patients are more tolerable
to single agent therapy than combination.

Based on the previous clinical experience in second line chemotherapy of advanced gastric
cancer, the single agent of PEP02, irinotecan and docetaxel are selected as the regimens for
this randomized phase II study. The efficacy and toxicity outcome of the three-arm design
will be a valuable reference for future combination therapy or phase III study design.

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

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

objective tumor response

Safety Issue:


Principal Investigator

David Cunningham

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Royal Marsden Hospital, London & Surrey, UK


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

November 2007

Completion Date:

December 2010

Related Keywords:

  • Stomach Neoplasms
  • Esophageal Neoplasms
  • Gastric Cancer
  • Stomach Cancer
  • Gastroesophageal
  • Gastroesophageal Junction
  • Esophageal Cancer
  • phase II
  • PEP02
  • randomization
  • randomisation
  • adenocarcinoma
  • locally advanced
  • metastatic
  • simon's two
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Stomach Neoplasms