Know Cancer

or
forgot password

A Randomized Multicenter Phase III Study Comparing Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment or Cisplatin Plus Capecitabine in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Advanced Gastric Cancer

Thank you

Trial Information

A Randomized Multicenter Phase III Study Comparing Paclitaxel Plus Capecitabine With Capecitabine Maintenance Treatment or Cisplatin Plus Capecitabine in Metastatic Adenocarcinoma of the Stomach or Esophagogastric Junction


Inclusion Criteria:



- Having signed informed consent

- Age≥ 18 years old

- Histologically confirmed gastric adenocarcinoma

- Unresectable recurrent or metastatic disease

- Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more
than 6 months

- Previous chemotherapy with capecitabine or cisplatin, if applicable, more than 12
months.

- Measurable disease according to the RECIST criteria

- Karnofsky performance status ≥60

- Life expectancy of ≥2 month

- No prior radiotherapy except radiotherapy at non-target lesion of the study more than
4 weeks

- ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)

- Serum albumin level ≥3.0g/dL

- Serum AKP < 2.5 times ULN

- Serum creatinine
- Bilirubin level < 1.5 ULN

- WBC>3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl

Exclusion Criteria:

- Brain metastasis (known or suspected)

- Previous systemic therapy for metastatic gastric cancer

- Inability to take oral medication

- Previous therapy targeting at angiogenesis or vasculogenesis pathway or other
targeted therapy

- Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry

- Contraindications of nuclear magnetic resonance image such as fitment of cardiac
pacemaker , nerve stimulator, or aneurysm clip, and metallic foreign body in eye
ball and so on.

- Allergic constitution or allergic history to protium biologic product or any
investigating agents.

- Severe heart disease or such history as recorded congestive heart failure,
uncontrolled cardiac arrhythmia, angina pectoris needing medication, cardiac valve
disease, severe abnormal ECG findings, cardiac infarction , or retractable
hypertension.

- Pregnancy or lactation period

- Any investigational agent within the past 28 days

- Other previous malignancy within 5 year, except non-melanoma skin cancer

- Previous adjuvant therapy with capecitabine+platinum,

- Pre-existing neuropathy>grade 1

- Legal incapacity

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:

Progression free survival

Outcome Time Frame:

3 year

Safety Issue:

No

Principal Investigator

Lin Shen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Peking University, School of oncology, Department of GI oncology

Authority:

China: Food and Drug Administration

Study ID:

PACLIC-C

NCT ID:

NCT01015339

Start Date:

November 2009

Completion Date:

August 2012

Related Keywords:

  • Advanced Gastric Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

Name

Location