Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment (PRECEPT)

Amgen

Status and phase: Completed; Phase 2

Conditions: Metastatic Cancer; Oncology; Metastatic Colorectal Cancer; Colon Cancer; Cancer; Rectal Cancer; Colorectal Cancer

Treatments: Drug: FOLFIRI; Biological: Panitumumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00411450

20060277

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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116 participants in 1 patient group

Panitumumab plus FOLFIRI

Experimental group

Description:

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.

Treatment:

Biological: Panitumumab

Drug: FOLFIRI