Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment

NCT ID: NCT00411450

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2010-10-31

Brief Summary

The primary objective is to estimate the effect of the human homolog of the Kirsten rat sarcoma-2 virus oncogene (KRAS) mutation status (wild type versus mutant) from tumor tissue on efficacy endpoints in patients with metastatic colorectal cancer (mCRC) receiving second-line chemotherapy with panitumumab after failing first-line treatment.

Conditions

Colon Cancer; Colorectal Cancer; Rectal Cancer; Cancer; Metastatic Cancer; Metastatic Colorectal Cancer; Oncology

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Panitumumab plus FOLFIRI

Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.

Group Type: EXPERIMENTAL

Panitumumab

Intervention Type: BIOLOGICAL

Administered by intravenous infusion

FOLFIRI

Intervention Type: DRUG

Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.

Interventions

Panitumumab

Administered by intravenous infusion

Intervention Type: BIOLOGICAL

FOLFIRI

Chemotherapy consisting of irinotecan with infusional 5-fluorouracil and leucovorin. Recommended dosage regimen and administration of FOLFIRI was based on local standard of care, the package insert for each product, and institutional guidelines.

Intervention Type: DRUG

Other Intervention Names

Vectibix

Eligibility Criteria

Inclusion Criteria

• Diagnosis of metastatic adenocarcinoma of the colon or rectum
• Available paraffin-embedded tumor tissue
• Failure of first line treatment containing fluoropyrimidine and oxaliplatin based chemotherapy with bevacizumab for mCRC
• Measurable disease
• Adequate hematologic, renal, hepatic and metabolic function

Exclusion Criteria

• Radiotherapy ≤ 2 weeks prior to Day 1 of Cycle 1
• Unresolved toxicity(ies) from prior anti cancer therapy that, in the opinion of the investigator, precludes the subject from study enrollment
• Prior irinotecan therapy, anti epidermal growth factor receptor (EGFr) therapy, or vaccine for the treatment of mCRC
• CYP3A4 enzyme inducers, inhibitors, and substrates (eg, phenytoin, phenobarbital, carbamazepine, ketoconazole, rifampin, rifabutin, and St. John's Wort) ≤ 2 weeks prior to Day 1 of Cycle 1
• Infection requiring systemic anti infectives completed ≤ 2 weeks prior to Day 1 of Cycle 1
• Clinically significant cardiovascular disease
• History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis)
• Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic event ≤ 8 weeks prior to Day 1 of Cycle 1
• Any significant bleeding ≤ 6 weeks prior to Day 1 of Cycle 1, per the investigator's judgement
• Gastroduodenal ulcer(s) determined by endoscopy to be active or uncontrolled gastrointestinal ulcer ≤ 4 weeks prior to Day1 of Cycle 1
• Any co-morbid disease or condition that could increase the risk of toxicity (eg, dihydropyrimidine deficiency, significant ascites, or pleural effusion)
• Major surgery (requiring general anesthesia), open biopsy, or significant traumatic injury ≤ 4 weeks prior to Day1 of Cycle 1. Subjects must have recovered from surgery and have no significant complications

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amgen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Amgen

References

Cohn AL, Shumaker GC, Khandelwal P, Smith DA, Neubauer MA, Mehta N, Richards D, Watkins DL, Zhang K, Yassine MR. An open-label, single-arm, phase 2 trial of panitumumab plus FOLFIRI as second-line therapy in patients with metastatic colorectal cancer. Clin Colorectal Cancer. 2011 Sep;10(3):171-7. doi: 10.1016/j.clcc.2011.03.022. Epub 2011 Apr 28.

Reference Type: BACKGROUND

PMID: 21855038 (View on PubMed)

Weeraratne D, Chen A, Pennucci JJ, Wu CY, Zhang K, Wright J, Perez-Ruixo JJ, Yang BB, Kaliyaperumal A, Gupta S, Swanson SJ, Chirmule N, Starcevic M. Immunogenicity of panitumumab in combination chemotherapy clinical trials. BMC Clin Pharmacol. 2011 Nov 9;11:17. doi: 10.1186/1472-6904-11-17.

Reference Type: DERIVED

PMID: 22070868 (View on PubMed)

Related Links

http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

20060277

Identifier Type: -

Identifier Source: org_study_id