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

Hebei Tumor Hospital

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: Docetaxel; Drug: Raltitrexed plus Docetaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT01836120

HBTH103

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Raltitrexed plus Docetaxel

Experimental group

Treatment:

Drug: Raltitrexed plus Docetaxel

Docetaxel

Active Comparator group

Treatment:

Drug: Docetaxel