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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00813072
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : March 2, 2012
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Esophageal Neoplasms Drug: PEP02 Drug: irinotecan Drug: docetaxel Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: 1. PEP02
liposome irinotecan
Drug: PEP02

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.

Other Name: liposome irinotecan

Active Comparator: 2. irinotecan Drug: irinotecan
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.
Other Name: Campto

Active Comparator: 3. docetaxel Drug: docetaxel

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.

Other Name: Taxetere

Primary Outcome Measures :
  1. objective tumor response

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00813072

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Sponsors and Collaborators
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Principal Investigator: David Cunningham The Royal Marsden Hospital, London & Surrey, UK

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: PharmaEngine Identifier: NCT00813072    
Other Study ID Numbers: PEP0206
EudraCT number: 2006-006452-35
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: March 2012
Keywords provided by PharmaEngine:
Gastric Cancer
Stomach Cancer
Gastroesophageal Junction
Esophageal Cancer
phase II
locally advanced
simon's two
Additional relevant MeSH terms:
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Esophageal Neoplasms
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors