Oxaliplatin, Capecitabine and Endostar as First Line Treatment for Patients With Advanced Colorectal Cancer

NCT00853684 | Unknown Phase 2 DMC

• 1 other identifier: 200902024
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

It is hypothesized that other anti-angiogenic agents such as endostar, may augment the effect of chemotherapy regimens in CRC. Endostar, a recombinant human endostatin which expressed and purified in E. coli, was approved by the SFDA for the treatment of non-small-cell lung cancer in 2005. Ling et al. found that endostar suppressed the VEGF-stimulated proliferation, migration, and tube formation of human umbilical vein endothelial cells (HUVECs) in vitro, and the antiangiogenic effects of endostar were correlated with the VEGF-triggered signaling. (Ling et al, 2007) A Chinese phase III clinical trial in advanced non-small-cell lung cancer, endostar--a new angiogenesis inhibitor prolonged the overall survival, time to progression and improved response rate. (Wang et al, 2005) Based on these results, the investigators design this phase II clinical trial of oxaliplatin, capecitabine and endostar as first line treatment, to evaluate whether endostar can bring survival benefits to patients with advanced colorectal cancer.

Conditions

Advanced Colorectal Cancer

Keywords

Advanced Colorectal Cancer; Oxaliplatin; Capecitabine; Endostar; efficacy

Outcome Measures

Primary Outcomes (1)

• Time to progression

  6 months

Secondary Outcomes (1)

• Overall survival

  2 years

Study Arms (1)

oxaliplatin, capecitabine plus endostar

EXPERIMENTAL

Drug: OXCE; Drug: Endostar

Interventions

OXCE DRUG

Oxaliplatin 130 mg/m2 iv drip D1, Capecitabine 1000 mg/m2 bid d1-14. Every three weeks.

Also known as: Capecitabine(Xeloda®)

oxaliplatin, capecitabine plus endostar

Endostar DRUG

Endostar 7.5 mg/m2 iv drip D1-14. Every 3 weeks.

Also known as: Endostar (a recombinant human endostatin)

oxaliplatin, capecitabine plus endostar

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed metastatic or recurrent colorectal tumors with no previous treatment for advanced disease.
• Age greater than or equal to 18 years.
• SWOG performance status 0-1.
• At least one measurable lesion according to the RECIST criteria which has not been irradiated (i.e. newly arising lesions in previously irradiated areas are accepted). Minimum indicator lesion size: \> 10 mm measured by spiral CT or \>20mm measured by conventional techniques.
• Have a negative serum pregnancy test within 7 days prior to initiation of chemotherapy (female patients of childbearing potential).
• Availability of tumor biopsy (paraffin embedded or fresh frozen) at the time of diagnosis and/or prior to study entry is required.
• Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.

You may not qualify if:

• Pregnant or lactating woman.
• Life expectancy \< 3 months.
• Serious, uncontrolled, concurrent infection(s) or illness(es)
• Any prior oxaliplatin treatment, with the exception of adjuvant therapy given \> 12 months prior to the beginning of study therapy
• Prior unanticipated severe reaction to fluoropyrimidine therapy, known hypersensitivity to 5-fluorouracil, or known DPD deficiency
• Prior unanticipated severe reaction or hypersensitivity to platinum based compounds.
• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer.
• Current, recent (within 4 weeks of first infusion on this study) or planned participation in an investigational drug study.
• Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) within the last 6 months.
• History of clinically significant interstitial lung disease and/or pulmonary fibrosis.
• History of persistent neurosensory disorder including but not limited to peripheral neuropathy.
• Presence of central nervous system or brain mets.
• Major surgery, open biopsy, or significant traumatic injury within 28 days prior to Day 0, or anticipation of need for major surgical procedure during the course of the study.
• Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
• Any of the following laboratory values:

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Department of Oncology, Ruijin Hospital, Medical School of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200035, China

RECRUITING

Related Publications (2)

• Sun L, Ye HY, Zhang YH, Guan YS, Wu H. Epidermal growth factor receptor antibody plus recombinant human endostatin in treatment of hepatic metastases after remnant gastric cancer resection. World J Gastroenterol. 2007 Dec 7;13(45):6115-8. doi: 10.3748/wjg.v13.45.6115.

  PMID: 18023113 BACKGROUND

• Xu F, Ma Q, Sha H. Optimizing drug delivery for enhancing therapeutic efficacy of recombinant human endostatin in cancer treatment. Crit Rev Ther Drug Carrier Syst. 2007;24(5):445-92. doi: 10.1615/critrevtherdrugcarriersyst.v24.i5.20.

  PMID: 18197781 BACKGROUND

MeSH Terms

Interventions

Capecitabine; endostar protein

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Weiguo Cao, MD

  Department of Oncology, Ruijin Hospital, Medical School of Shanghai Jiaotong University

  STUDY CHAIR

Central Study Contacts

Weiguo Cao, MD

CONTACT

+86 21 6415 5988; rjyyzlk@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 26, 2009
• First Posted: March 2, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

CN (1)