Paclitaxel and Irinotecan in Advanced Gastric Cancer

NCT01136031 | Completed Phase 1

• 1 other identifier: H-0703-042-201
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

• Usually the combination of fluoropyrimidine with platinum is used as a first line chemotherapy (for example, 5-FU+cisplatin, capecitabine+cisplatin, S-1+ cisplatin, 5-FU+oxaliplatin) in advanced gastric cancer.
• After failure with this combination, taxane-based regimen or irinotecan-based regimen is usually used. But, as a second-line regimen, the combination of topoisomerase inhibitor with taxane has not been fully evaluated until now.
• So we designed this phase I/II study to evaluate the efficacy and toxicity of second-line chemotherapy with paclitaxel and irinotecan in fluoropyrimidine and platinum-pretreated advanced gastric cancer.

Conditions

Advanced Gastric Cancer

Keywords

advanced gastric cancer; 1st-line failure

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (phase I part)

  during first cycle (first 3 week)

• response rate (phase II part)

  every 2 cycles response evaluation

Secondary Outcomes (4)

• recommended phase II dose

  after the determining MTD

• time to progression

  at the time of disease progression

• overall survival

  at the time of death

• toxicities

  every time of physical exam and laboratory evaluation

Study Arms (1)

Paclitaxel and irinotecan

EXPERIMENTAL

Drug: Paclitaxel and irinotecan

Interventions

Paclitaxel and irinotecan DRUG

In phase I part, Level Paclitaxel (mg/m²) Irinotecan (mg/m²) 1. 100 100 2. 100 120 3. 135 120 4. 135 160 every 3 week

Paclitaxel and irinotecan

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 70 years
• A patient who is able to walk and should have ECOG performance status of 0-1.
• Histologically confirmed adenocarcinoma of the stomach
• Unresectable locally advanced or initially metastatic or recurrent after curative resection
• Prior one regimen chemotherapy including fluoropyrimidine and platinum. (FP, XP, TS-1+cisplatin, FOLFOX)
• A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT), or 20 mm or longer in conventional CT (it should be used by a consistent method during the study period).
• A patient with the willingness to comply with the study protocol during the study period and capable of complying with it.
• A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages.

You may not qualify if:

• A patient with no measurable disease
• A patient with previous chemotherapy without containing fluoropyrimidine or platinum.
• A patient with UGT1A1\*28 allele ((TA)7/7 homozygosity)
• A patient with previous active or passive immunotherapy.
• A patient with intestinal obstruction or impending obstruction, recent active upper GI bleeding
• A pregnant or lactating patient
• A patient of childbearing potential without being tested for pregnancy at baseline or with being tested for positive. (A postmenopausal woman with the amenorrhea period of at least 12 months or longer is considered to have non-childbearing potential.)
• A man or woman of childbearing potential who has no willingness to use a contraceptive measure during the study.
• A patient with history of another malignant disease within past 5 years, except curatively treated basal cell carcinoma of the skin and cervical carcinoma in situ are excluded.
• A patient with history of uncontrolled seizures, central nervous system disorder or psychiatric disorders that are considered clinically significant by the investigator that would prohibit the understanding of informed consent or that may be considered to interfere with the compliance of the administration of the study medications.
• A patient with clinically significant (i.e. active) heart disease (e.g. congestive heart failure, symptomatic coronary artery diseases, cardiac arrhythmias, etc) or myocardial infarction within past 12 months.
• A patient with interstitial pneumonia or diffused symptomatic fibrosis of the lungs.
• Organ allogenic transplantation requiring immunosuppressive therapy.
• A patient who developed uncontrolled serious infection or other uncontrolled serious concomitant diseases.
• A patient with moderate or severe renal insufficiency or serum creatinine \> 1.5 X upper limit of normal\].

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Interventions

Paclitaxel; Irinotecan

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Do-Youn Oh, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2010
• First Posted: June 3, 2010
• Study Start: January 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 20, 2015

Record last verified: 2010-05

Locations

KR (1)