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A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer


Phase 1/Phase 2
18 Years
70 Years
Not Enrolling
Both
Gastric Cancer

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Trial Information

A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer


Primary objectives :

To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate
the overall response rate in phase II study

Secondary objectives :

1. To evaluate the safety and tolerability of the treatment combination.

2. To estimate overall survival.

3. To estimate the time to progression and the duration of overall response.


Inclusion Criteria:



- Histologically documented gastric adenocarcinoma including adenocarcinoma of the
esophagogastric junction

- 18 ≤ age ≤ 70

- ECOG performance status of 0 - 2

- At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥ 2 cm in
physical examination

- Previously untreated metastatic gastric cancer patients or relapsed gastric cancer
patients (patients with recurrence at least 6 months from the date of last
administration of adjuvant chemotherapy and/or radiation therapy with 5-FU and/or
leucovorin containing regimen will be included in the study)

- Written informed consent

- Minimum life expectancy of 12 weeks

- Adequate liver, renal, bone marrow functions as evidence by the following; Absolute
neutrophil count > 1.5 x 109/L; platelets > 100 x 109/L; ASAT and/or ALAT < 3 UNL;
serum creatinine ≤ 1.5 ULN

Exclusion Criteria:

- Any other malignancies within the past 5 years except skin basal cell cancer or CIS
of cervix

- Serious comorbid diseases

- Pregnancy or lactation

- Previous history of drug allergy to one of the drugs in the study regimen

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To define the dose-limiting toxicity and maximum tolerated dose in phase I study To evaluate the overall response rate in phase II study

Outcome Time Frame:

Two years

Safety Issue:

Yes

Principal Investigator

Young Suk Park, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center, Seoul, KOREA

Authority:

Korea: Food and Drug Administration

Study ID:

2005-10-047

NCT ID:

NCT00533533

Start Date:

January 2006

Completion Date:

June 2008

Related Keywords:

  • Gastric Cancer
  • Docetaxel,Oxaliplatin
  • Phase I/II study
  • Advanced gastric cancer
  • First line treatment
  • Advanced gastric cancer with measurable disease
  • Stomach Neoplasms

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