Clinical trial NCT01839773: Phase 3 Study to Compare Efficacy and Safety of DHP107 vs. Taxol® in Patients With Metastatic or Recurrent Gastric Cancer
Official title: A Randomized, Open-label, Multicenter, Phase 3 Study for Efficacy and Safety Assessment of DHP107 (Oral Paclitaxel) vs. Taxol® in Patients With Metastatic or Recurrent Gastric Cancer After Failure of First-line Chemotherapy With Fluoropyrimidine +/- Platinum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stage IV Gastric Cancer
Keywords: Stomach Neoplasms
Cancer of Stomach
Gastric Cancer
Gastric Neoplasms
Neoplasms, Gastric
Neoplasms, Stomach
Stomach Cancer
paclitaxel
Taxol
Lead sponsor: Daehwa Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-04-25
Enrollment: 238
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of DHP107 (Oral paclitaxel) in comparison to Taxol®(IV paclitaxel) in Patients With Metastatic or Recurrent Gastric Cancer After Failure of 1st Line Chemotherapy With Fluoropyrimidine +/- Platinum.


Eligibility criteria: Inclusion Criteria:

1. ≥20 years of age
2. Histologically or cytologically confirmed unresectable, recurrent or metastatic gastric cancer
3. Failure of a first line therapy with fluoropyrimidine +/- platinum for metastatic or recurrent disease.(Adjuvant chemotherapy is not considered as a first line chemotherapy unless recurrence developed within 6 months of completion of adjuvant therapy.)
4. Adequate bone marrow, liver and renal functions
5. INR ≤ 2.0
6. ECOG performance status ≤ 2
7. Neuropathy grade ≤ 1
8. Life expectancy of at least 3 months
9. Measurable lesion according to RECIST version 1.1 on CT scan
10. Written informed consent
11. Patients of child bearing age have to agree to the usage of adequate contraception from before the registration to the study, during the participation period and 90 days after the end of treatment. Female of child bearing age has to show negative for urin pregnancy test within 7 days from beginning of the start of administration. Amenorrhea status has to be sustained for at least 12 months to be considered non-pregnant in case of postmenstrual women.

Exclusion Criteria:

1. Major infectious disease, neurological disorder, or bowel obstruction.
2. Patients with CNS metastases(confirmed through brain imaging if there are symptoms)
3. Patient diagnosed with another cancer type (except non-melanoma skin cancer, cervical cancer, or any other cancer that did not recur or metastasized for more than 5 years and considered as complete remission can be registered)
4. Patient who received radiation therapy within past 2 weeks or who had major surgery including organ resection within past 4 weeks from random assignment date
5. Patient with the history of failure to the taxane chemotherapy
6. Patient who need chronic concomitant use of P glycoprotein, immune suppressor, proton pump inhibitor, or H2-receptor antagonist during the period of clinical trial
7. Chronic treatment using steroid (except oral, local injection, or for externally applied) or other immune suppressor
8. Patient with myocardial infarction, congestive heart failure, arrhythmia showing abrupt change in the ECG, severe or unstable angina, or other serious heart disease
9. Patient with other serious internal disease (chronic obstructive or chronic inhibitory lung disease including shortness of breathe at rest due to all reasons, uncontrollable diabetes and hypertension)
10. History of abuse of a drug or alcohol within 3 months
11. Lactating or pregnant women, or patient (or spouse) who has no intension of using, or cannot use very effective mean of contraception
12. Patient who has or is suspected to have problem in bile acid secretion
13. Patient with active gastrointestinal bleeding, or taking oral anti- vitamine K (With the exception of low dose of Warfarin and acetylsalicylic acide when INR≤2.0)
14. History of serious hypersensitive reaction to the main ingredient or the excipient of the investigational drug
15. History of being seropositive for HIV (HIV test is not a prerequisite).
16. Patients with gastrointestinal dysfunction or on enteral feeding
17. Other patients who are deemed inadequate to participate in the clinical trial by the investigator

Primary outcomes:
measure: Progression Free Survival
timeFrame: Participants will be followed until progression, an expected average of 4 months.
Secondary outcomes:
measure: Overall Survival
timeFrame: Until 6 months after the last participant is enrolled, assessed up to 24 months.
measure: Overall Response Rate
timeFrame: Participants will be followed every 6 weeks until progression, an expected average of 4 months.
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Chungnam
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References:
citation: Kang YK, Ryu MH, Park SH, Kim JG, Kim JW, Cho SH, Park YI, Park SR, Rha SY, Kang MJ, Cho JY, Kang SY, Roh SY, Ryoo BY, Nam BH, Jo YW, Yoon KE, Oh SC. Efficacy and safety findings from DREAM: a phase III study of DHP107 (oral paclitaxel) versus i.v. paclitaxel in patients with advanced gastric cancer after failure of first-line chemotherapy. Ann Oncol. 2018 May 1;29(5):1220-1226. doi: 10.1093/annonc/mdy055.