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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PharmaEngine
ClinicalTrials.gov Identifier:
NCT00813072
First received: December 18, 2008
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Stomach Neoplasms
Esophageal Neoplasms
Drug: PEP02
Drug: irinotecan
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by PharmaEngine:

Primary Outcome Measures:
  • objective tumor response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: November 2007
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813072

Locations
Bosnia and Herzegovina
Clinical Hospital Mostar
Mostar, Bosnia and Herzegovina, 36 000
Clinical Centre University of Sarajevo
Sarajevo, Bosnia and Herzegovina, 71 000
Croatia
University Hospital Centre Rijeka
Rijeka, Croatia, 51 000
University Hospital Centre Dubrava
Zagreb, Croatia, 10 000
University Hospital Centre Zagreb
Zagreb, Croatia, 10 000
Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
National Cancer Center
Seoul, Korea, Republic of, 410-769
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Hospital General Universitario de Elche
Elche, Spain, 03203
Hospital Clínico San Carlos
Madrid, Spain, 28040
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Taiwan
Chang Gung Memorial Hospital - Chiayi
Chiayi, Taiwan
Chang Gung Memorial Hospital - LinKou
LinKou, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Mackay Memorial Hospital
Taipei, Taiwan, 25115
Taipei Veterans General Hospital
Taipei, Taiwan, 112
United Kingdom
Addenbrookes Hospital Oncology Center
Cambridge, United Kingdom, CB2 2QQ
Guy's & St Thomas' NHS Foundation Trust
London, United Kingdom, SE19RT
Kent Oncology Centre, Maidstone Hospital
Maidstone, United Kingdom, ME16 9QQ
Southampton University Hospital
Southampton, United Kingdom, SO16 6YD
The Royal Marsden Hospital
Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
PharmaEngine
Investigators
Principal Investigator: David Cunningham The Royal Marsden Hospital, London & Surrey, UK
  More Information

No publications provided by PharmaEngine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PharmaEngine
ClinicalTrials.gov Identifier: NCT00813072     History of Changes
Other Study ID Numbers: PEP0206, EudraCT number: 2006-006452-35
Study First Received: December 18, 2008
Last Updated: March 1, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Spain: Ministry of Health and Consumption
Taiwan: Department of Health
Croatia: Ministry of Health and Social Care
Korea: Food and Drug Administration
Bosnia: Federal Ministry of Health

Keywords provided by PharmaEngine:
Gastric Cancer
Stomach Cancer
Gastroesophageal
Gastroesophageal Junction
Esophageal Cancer
phase II
PEP02
randomization
randomisation
adenocarcinoma
locally advanced
metastatic
simon's two

Additional relevant MeSH terms:
Adenocarcinoma
Neoplasms
Esophageal Neoplasms
Stomach Neoplasms
Carcinoma
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
Irinotecan
Docetaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on July 31, 2014