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A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01836120
Recruitment Status : Unknown
Verified April 2013 by Hebei Tumor Hospital.
Recruitment status was:  Active, not recruiting
First Posted : April 19, 2013
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Hebei Tumor Hospital

Brief Summary:
A study of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with Gastric Cancer.The purpose of this study is to compare the activity of Raltitrexed plus Docetaxel versus Docetaxel as second-line chemotherapy in subjects with gastric carcinoma by estimating progression free survival (PFS) in each treatment arm.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Raltitrexed plus Docetaxel Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Raltitrexed Plus Docetaxel Versus Docetaxel as Second-line Chemotherapy in Subjects With Gastric Cancer
Study Start Date : April 2013
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
Experimental: Raltitrexed plus Docetaxel Drug: Raltitrexed plus Docetaxel

Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d

1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)


Active Comparator: Docetaxel Drug: Docetaxel
Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 1 year ]
  2. Overall Survival (OS) [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent form
  2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-2;
  3. Histologically or cytologically confirmed gastric cancer;
  4. The first-line chemotherapy failure (required containing 5-fluorouracil)
  5. At least have one measurable disease(according to RECIST, Response Evaluation Criteria in Solid Tumors )
  6. Life expectancy of at least 3 months;

Exclusion Criteria:

  1. Received any prior treatment including Raltitrexed;
  2. Active or uncontrolled infection;
  3. Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
  4. Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836120


Locations
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China, Hebei
Hebei Tumor Hospital
Shijiazhuang, Hebei, China, 050011
Sponsors and Collaborators
Hebei Tumor Hospital

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Responsible Party: Hebei Tumor Hospital
ClinicalTrials.gov Identifier: NCT01836120     History of Changes
Other Study ID Numbers: HBTH103
First Posted: April 19, 2013    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013
Keywords provided by Hebei Tumor Hospital:
second-line chemotherapy
Raltitrexed
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Raltitrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Folic Acid Antagonists
Enzyme Inhibitors