Phase 2
N=116
Panitumumab Regimen Evaluation in Colorectal Cancer to Estimate Primary Response to Treatment
Colon Cancer · Colorectal Cancer · Rectal Cancer · Cancer · Metastatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00411450 ↗Enrolled (actual)
116
Serious AEs
40.0%
Results posted
Feb 2016
Primary outcome: Primary: Objective Response Rate at Weeks 17 and 25 — 20; 14; 22; 14 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Panitumumab (Biological); FOLFIRI (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate at Weeks 17 and 25 |
20; 14; 22; 14 | — |
| PRIMARY Best Response During Second-Line Treatment |
23; 16 | — |
| PRIMARY Progression-free Survival Rate at Weeks 17 and 25 |
67; 55; 52; 41 | — |
| PRIMARY Progression-free Survival Time |
26; 19 | — |
| PRIMARY Disease Control Rate at Weeks 17 and 25 |
64; 58; 64; 58 | — |
| PRIMARY Duration of Response |
29; 23 | — |
| PRIMARY Overall Survival |
50; 31 | — |
| PRIMARY Time to Treatment Failure |
19; 15 | — |
| PRIMARY Time to Progression |
26; 17 | — |
| PRIMARY Time to Response |
9.1; 9.3 | — |
| SECONDARY Number of Participants With Adverse Events |
115; 94; 107; 112; 56; 65 | — |
| SECONDARY Number of Participants With Grade 4 Laboratory Toxicities |
1; 4; 8; 1; 3; 1 | — |
| SECONDARY Number of Participants Who Developed Antibodies to Panitumumab |
1; 0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00411450). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.