Study of Nimotuzumab to Treat Colorectal Cancer
Recruitment status was Recruiting
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Purpose
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Colorectal Cancer |
Drug: Nimotuzumab and chemotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase IIa Study of Nimotuzumab Plus Irinotecan as Second-line Treatment in Metastatic Colorectal Cancer With Wild Type K-ras |
- Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated. [ Time Frame: within study period ] [ Designated as safety issue: Yes ]
- To determine the complete response rate, partial rate, disease response rate, disease control rate in the patients subject to treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | April 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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Drug: Nimotuzumab and chemotherapy
Experimental: Nimotuzumab and Irinotecan
the chemotherapy treatment: Irinotecan (180 mg/m2/time, 1 time/14 days, until disease progression)
the nimotuzumab treatment: 3 levels (200 mg/w, 400 mg/w, 600 mg/w, weekly, until disease progression)
Nimotuzumab and Irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment.Irinotecan will be administered once every 14 days,the dosage is 180mg/m2; Nimotuzumab treatment be divided 3 levels:200mg/w,400mg/w,600mg/w,weekly.The patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks,when the total result is the CR or PR, the result of the 6th and the 12th week should be compared.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Informed consent form signed before performing any of the study's specific procedures.
- ECOG performance status 0-2.
- Age > 18,both genders.
- Metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer
- Disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment
- At least 1 measurable lesions ,( longest diameter≥ 1 cm by spiral computed tomography (CT) scan or MRI)
- Life expectancy more than 3 months.
- K-ras is wild type
- Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
- Liver metastasis, lesions smaller than 50% of the liver; Lung metastasis, lesions smaller than 30% of the lung
- Haemoglobin≥90g/L , granulocyte≥1.5×109/L ,WBC ≥3×109/L, platelet count≥100×109/L
- TBIL≤ 1.5 x ULN ,ALK≤ 2.5 x ULN or ≤ 5ULN(Liver metastasis),AST and ALT≤ 2.5 x ULN or ≤ 5ULN(Liver metastasis),Creatinine ≤ 1.5 x ULN
- No brain metastasis
Exclusion Criteria:
- Previous radiotherapy at lesions within three months
- Other first line chemo-agents treatment except oxaliplatin ± fluorouracil
- Received other anti EGFR monoclonal antibody treatment
- Complete or incomplete intestinal obstruction
- Participation in other interventional clinical trials within 1 month
- Psychiatric disease affected cognitive ability, including brain metastasis
- Peripheral neuropathy lesion is more than I stage
- History of serious allergic or allergy
- Pregnant or breast-feeding women
- Patients with the history of Serious lung or hear disease
- Other malignant tumor
Contacts and Locations| Contact: Shen Lin | 86-01-88196561 |
| China, Guangdong | |
| Sun Yat-Sen University Cancer Center | Not yet recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: ruihua Xu, M.D., Ph.D. 13922206676 xurh@mail.sysu.edu.cn | |
| China | |
| Peking University, School of Oncology, Beijing Cancer Hospital & Institute | Recruiting |
| Beijing, China | |
| Contact: Jun Zhou, MD. PhD 88196088 joelbmu@126.com | |
| China People's Liberation Army (PLA)81 Hospital | Not yet recruiting |
| Nanjing, China | |
| Contact: Shukui Qin 13905158713 qinshukui@csco.org.cn | |
| Principal Investigator: | Shen Lin | Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute |
More Information
No publications provided
| Responsible Party: | Shen Lin, Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute |
| ClinicalTrials.gov Identifier: | NCT00972465 History of Changes |
| Other Study ID Numbers: | BT-CRC-T |
| Study First Received: | September 4, 2009 |
| Last Updated: | September 4, 2009 |
| Health Authority: | China: Food and Drug Administration China: Ethics Committee |
Keywords provided by Peking University:
|
nimotuzumab colorectal cancer chemotherapy |
Additional relevant MeSH terms:
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013