Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With mCRC

NCT00475293 | Completed Phase 2

• 1 other identifier: TTD-06-04
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the objective response rate (ORR) when panitumumab is administered in combination with irinotecan as 2nd-line therapy in subjects with previously treated metastatic colorectal cancer (mCRC).

Conditions

Metastatic Colorectal Cancer

Keywords

metastatic colorectal cancer; 2nd-line Therapy; panitumumab; irinotecan

Outcome Measures

Primary Outcomes (1)

• objective response rate

  2007-2010

Secondary Outcomes (2)

• disease control rate, duration of response, time to response, progression-free survival, time to progression,time to treatment failure,duration of stable disease

  2007-2010

• adverse events

  2007-2010

Study Arms (1)

1

EXPERIMENTAL

Drug: Panitumumab and CPT-11

Interventions

Panitumumab and CPT-11 DRUG

Panitumumab will be administered by IV infusion on day 1 of each cycle just prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg Irinotecan: 350 or 300 mg/m2. day 1 One treatment cycle is defined as the 21 day period following the commencement of treatment with panitumumab + irinotecan plus additional time, as needed, for the resolution of irinotecan-related toxicities

1

Eligibility Criteria

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

You may qualify if:

• Man or woman \> 18 years of age
• Competent to comprehend, sign, and date an IEC-approved informed consent form
• Histologically or cytologically-confirmed metastatic adenocarcinoma of the colon or rectum.
• Radiographically documented disease progression per modified RECIST criteria either while receiving or ≤ 6 months after the last dose of prior first-line chemotherapy for mCRC
• At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST criteria.
• If subject has prior history of cancer other than colorectal carcinoma, basal cell carcinoma, or cervical carcinoma in situ, then subject must not have had treatment or active disease within 5 years.
• Prior radiotherapy is acceptable.
• One and only one prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine-based chemotherapy.
• ECOG performance status of 0, 1 or 2
• Life expectancy ≥ 3 months
• Hematologic function:ANC \> 1.5 x 109/L, Platelet count \> 100 x 109/L, Hemoglobin \> 10 g/dL
• Renal function: Creatinine \< 1.5 mg/dL
• Hepatic function: AST and ALT \< 3 x ULN (if liver metastases \< 5 x ULN)
• Bilirubin \< 2 x ULN

You may not qualify if:

• No more than one prior chemotherapy regimen for mCRC consisting of first-line fluoropyrimidine-based chemotherapy. (Prior adjuvant fluoropyrimidine-based chemotherapy is allowed)
• Prior systemic therapy for the treatment of metastatic colorectal carcinoma with the exception of adjuvant fluoropyrimidine-based chemotherapy given at least 6 months prior to enrolment.
• Central nervous system/brain metastases
• Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
• Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment small molecule EGFr tyrosine kinase inhibitors (eg, erlotinib)
• History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline chest CT scan
• Treatment for systemic infection within 14 days before initiating study treatment
• Active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as \> 4 loose stools per day)
• History of Gilbert's syndrome or dihydropyrimidine deficiency
• History of any medical condition that may increase the risks associated with study participation or may interfere with the interpretation of the study results
• Known positive test for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
• subject allergic to the ingredients of the study medication or to Staphylococcus protein A
• Any co-morbid disease that would increase risk of toxicity
• Any kind of disorder that compromises the ability of the subject to give written informed consent and/or comply with the study procedures
• Any investigational agent within 30 days before enrolment

Sponsors & Collaborators

• Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD): lead
• Amgen: collaborator

Study Sites (1)

Spanish Cooperative Group for Gastrointestinal Tumour Therapy

Madrid, 28046, Spain

Location

Related Publications (1)

• Carrato A, Gomez A, Escudero P, Chaves M, Rivera F, Marcuello E, Gonzalez E, Gravalos C, Constenla M, Manzano JL, Losa F, Maurel J, Duenas R, Massuti B, Gallego J, Aparicio J, Anton A, Aranda E. Panitumumab and irinotecan every 3 weeks is an active and convenient regimen for second-line treatment of patients with wild-type K-RAS metastatic colorectal cancer. Clin Transl Oncol. 2013 Sep;15(9):705-11. doi: 10.1007/s12094-012-0993-x. Epub 2013 Jan 29.

  PMID: 23359181 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Alfredo Carrato, MD

  Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: May 17, 2007
• First Posted: May 21, 2007
• Study Start: May 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 13, 2013

Record last verified: 2013-02

Locations

ES (1)