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Phase I Clinical Trial of 7-Day Capecitabine in Combination with Docetaxel and Oxaliplatin in the Treatment of Advanced Malignant Solid Tumors

Phase I Clinical Trial of 7-Day Capecitabine in Combination with Docetaxel and Oxaliplatin in the Treatment of Advanced Malignant Solid Tumors

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONRC-13004023
Enrollment
Unknown
Registered
2013-12-07
Start date
2009-10-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced malignant solid tumor

Interventions

1:docetaxel 75 mg/m2, d1
q21d+oxaliplatin100mg/m2, d1
q21d+capecitabine1000mg/m2, bid, d1-7
q21d
2:docetaxel 75 mg/m2, d1
q21d+oxaliplatin120mg/m2, d1
3:docetaxel 75 mg/m2, d1
q21doxaliplatin100mg/m2, d1
q21d+capecitabine1250mg/m2, bid, d1-7

Sponsors

Affiliated Cancer Hospital of Guangxi Medical University/Cancer Hospital of Guangxi Zhuang Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
36 Years to 64 Years

Inclusion criteria

Inclusion criteria: (1) Patients who were histologically or cytologically confirmed to have advanced head and neck squamous cell carcinoma, esophageal or gastric cancer; (2) Patients were not previously treated with docetaxel, oxaliplatin or capecitabine, and their last chemotherapy cycle was completed at least 4 weeks prior to enrollment; (3) Patients aged 18 to 70 years; (4) ECOG PS (Eastern Cooperative Oncology Group Performance Status) =4.0*10^9/L, ANC >=2.0*10^9/L, HB >=100 g/L, PLT >=100.0*10^12/L; (7) Patients with AST and ALT <=2.5*UNL (upper normal limit) in liver function tests and normal renal function; (8) Patients who had provided informed consent; (9) The trial was approved by the local ethics committees in all participating institutions.

Exclusion criteria

Exclusion criteria: (1) Patients with allergies to docetaxel, oxaliplatin or capecitabine; (2) Patients who could not take oral capecitabine; (3) Patients with malabsorption syndromes; (4) Patients with serious heart and liver dysfunctions; (5) Patients with brain metastases.

Design outcomes

Primary

MeasureTime frame
DLT;MTD;

Countries

China

Contacts

Public ContactZhi-hui Liu

Affiliated Cancer Hospital of Guangxi Medical University

lzhh101@sina.com+86 13877155907

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026