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

NCT ID: NCT00813072

Last Updated: 2012-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-12-31

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

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.

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1. PEP02

liposome irinotecan

Group Type: EXPERIMENTAL

PEP02

Intervention Type: DRUG

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.

2. irinotecan

Group Type: ACTIVE_COMPARATOR

irinotecan

Intervention Type: DRUG

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.

3. docetaxel

Group Type: ACTIVE_COMPARATOR

docetaxel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

liposome irinotecan; Campto; Taxetere

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaEngine

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Cunningham

Role: PRINCIPAL_INVESTIGATOR

The Royal Marsden Hospital, London & Surrey, UK

Locations

Clinical Hospital Mostar

Mostar, , Bosnia and Herzegovina

Clinical Centre University of Sarajevo

Sarajevo, , Bosnia and Herzegovina

University Hospital Centre Rijeka

Rijeka, , Croatia

University Hospital Centre Dubrava

Zagreb, , Croatia

University Hospital Centre Zagreb

Zagreb, , Croatia

Samsung Medical Center

Seoul, , South Korea

Asan Medical Center

Seoul, , South Korea

National Cancer Center

Seoul, , South Korea

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Hospital General Universitario de Elche

Elche, , Spain

Hospital Clínico San Carlos

Madrid, , Spain

Hospital Universitario Marques de Valdecilla

Santander, , Spain

Chang Gung Memorial Hospital - Chiayi

Chiayi City, , Taiwan

Chang Gung Memorial Hospital - LinKou

Linkou District, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

Addenbrookes Hospital Oncology Center

Cambridge, , United Kingdom

Guy's & St Thomas' NHS Foundation Trust

London, , United Kingdom

Kent Oncology Centre, Maidstone Hospital

Maidstone, , United Kingdom

Southampton University Hospital

Southampton, , United Kingdom

The Royal Marsden Hospital

Surrey, , United Kingdom

Countries

Bosnia and Herzegovina; Croatia; South Korea; Spain; Taiwan; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 23406728 (View on PubMed)

Other Identifiers

EudraCT number: 2006-006452-35

Identifier Type: -

Identifier Source: secondary_id

PEP0206

Identifier Type: -

Identifier Source: org_study_id