A Phase 2, Randomized, Double Blind, Placebo Controlled Study of AMG 386 in Combination With FOLFIRI in Subjects With Previously Treated Metastatic Colorectal Carcinoma

Amgen

Status and phase: Completed; Phase 2

Conditions: Metastatic Cancer; Oncology; Metastatic Colorectal Cancer; Gastrointestinal Cancer; Metastases; Colon Cancer; Carcinoma; Cancer; Rectal Cancer; Colorectal Cancer

Treatments: Drug: AMG 386 Placebo; Drug: AMG 386; Drug: FOLFIRI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00752570

20070307

Details and patient eligibility

About

This clinical trial will compare the efficacy and safety of the combination of AMG 386 and FOLFIRI with FOLFIRI alone in second line treatment of metastatic colorectal cancer.

Enrollment: 144 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed adenocarcinoma of the colon or rectum in patients who are presenting with metastatic disease
• One and only one prior chemotherapy regimen for metastatic disease consisting of the combination of a fluoropyrimidine-based chemotherapy and an oxaliplatin-based chemotherapy. Prior adjuvant chemotherapy used prior to the onset of metastatic disease is permitted
• At least one uni dimensionally measurable lesion per modified RECIST criteria. All sites of disease must be evaluated <= 28 days before randomization
• Radiographically documented disease progression per modified RECIST criteria either while receiving or <= 6 months after the last dose of prior chemotherapy regimen for metastatic disease
• ECOG performance status of 0 or 1
• Man or woman >= 18 years of age
• Adequate end organ assessments by laboratory studies (hematological and chemistries)
• Life expectancy >= 3 months

Exclusion criteria

• Exclude subjects with a history of prior malignancy, except:

  • Malignancy treated with curative intent and with no known active disease present for >= 3 years before enrollment and felt to be at low risk for recurrence by treating physician
  • Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
  • Adequately treated cervical carcinoma in situ without evidence of disease
  • Prostatic intraepithelial neoplasia without evidence of prostate cancer

• Prior irinotecan therapy

• Systemic chemotherapy, hormonal therapy, or immunotherapy <= 21 days prior to randomization

• Experimental or approved proteins/antibodies (eg, bevacizumab) <= 30 days prior to randomization

• Clinically significant cardiac disease within 12 months prior to randomization, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, cerebrovascular accident, transient ischemic attack, congestive heart failure, or arrhythmias not controlled by outpatient medication, percutaneous transluminal coronary angioplasty/stent

• Known allergy or hypersensitivity to irinotecan, 5 FU (known dihydropyrimidine dehydrogenase deficiency) or leucovorin

• Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as >= CTC grade 2 [CTCAE version 3.0])

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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144 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Description:

AMG 386 placebo QW, FOLFIRI Q2W

Treatment:

Drug: FOLFIRI

Drug: AMG 386 Placebo

1

Active Comparator group

Description:

Arm 1 : AMG 386 10 mg/kg QW, FOLFIRI Q2W

Treatment:

Drug: FOLFIRI

Drug: AMG 386