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Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Gastric Cancer

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Trial Information

Randomized Phase II Trial of Sunitinib and Docetaxel in Advanced Gastric Cancer Patients Who Had Prior Chemotherapy With Fluoropyrimidine and Platinum


This is a randomized phase II trial of Sunitinib and Docetaxel in advanced gastric cancer
patients who had prior chemotherapy with Fluoropyrimidine and Platinum.


Inclusion Criteria:



1. histologically or cytologically confirmed diagnosis of gastric adenocarcinoma or
gastroesophageal junction adenoca (i.e. an adenocarcinoma with > 50% extension in the
stomach)

2. patients must present with stage IV disease not amenable to surgery, radiation or
combined modality therapy with curative intent. Patients previously undergoing local
treatment (surgery and/or radiation) must have subsequently progressed or recurred

3. prior chemotherapy wit fluoropyrimidine and platinum

4. measurable or evaluable disease according to RECIST

5. age, 18 years or older

6. ECOG performance status 0 - 2

7. adequate organ function as defined by the following criteria absolute neutrophil
count (ANC) ≥ 1,500/ul platelets ≥ 100,000/ul AST/ALT ≤ 2.5 x ULN, ≤ 5.0 x ULN if
liver involvement Total serum bilirubin ≤ 2.0 mg/dL

8. life expectancy of ≥ 3 months

9. signed written informed consent

Exclusion Criteria:

1. more than one prior chemotherapy for metastatic disease

2. severe co-morbid illness and/or active infections

3. NCI CTCAE Grade 3 hemorrhage from any cause < 4 weeks before enrollment

4. preexisting uncontrolled hypertension as documented by 2 baseline blood pressure
readings taken at least 1 hour apart

5. pregnant or lactating women

6. active CNS metastases not controllable with radiotherapy or corticosteroids

7. active and uncontrollable bleeding from gastrointestinal tract

8. known history of hypersensitivity to study drugs

9. prior treatment with sunitinib

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

time to progression

Outcome Time Frame:

every 6 weeks

Safety Issue:

No

Principal Investigator

Jeeyun Lee, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center, Seoul, Korea

Authority:

Korea: Food and Drug Administration

Study ID:

2008-09-031

NCT ID:

NCT01238055

Start Date:

November 2008

Completion Date:

October 2012

Related Keywords:

  • Advanced Gastric Cancer
  • advanced gastric cancer
  • sunitinib
  • docetaxel
  • fluoropyrimidine platinum based chemotherapy
  • Stomach Neoplasms

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