Phase 2
N=28
Dual Epidermal Growth Factor Receptor Inhibition With Erlotinib and Panitumumab With or Without Chemotherapy for Advanced Colorectal Cancer
Colorectal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00940316 ↗Enrolled (actual)
28
Serious AEs
32.1%
Results posted
May 2019
Primary outcome: Primary: Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD) — 0; 1; 0; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- panitumumab (Biological); erlotinib hydrochloride (Drug); irinotecan hydrochloride (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response Rate Based on Complete Response (CR)+ Partial Response (PR) + Stable Disease (SD) |
0; 1; 0; 4; 3; 0 | — |
| SECONDARY Time to Disease Progression |
— | — |
| SECONDARY Time to Treatment Failure |
— | — |
| SECONDARY Toxicity of the Combination of Study Drugs |
3; 1; 0; 0; 7; 0 | — |
| SECONDARY Effect on Downstream Targets of Epidermal Growth Factor Receptor (EGFR) in Skin Rash Associated With Pharmacologic EGFR Inhibition |
— | — |
Summary
RATIONALE: Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Panitumumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether erlotinib hydrochloride given together with panitumumab is more effective with or without irinotecan in treating patients with metastatic colorectal cancer.
PURPOSE: This randomized phase II trial is studying giving erlotinib hydrochloride together with panitumumab to see how well it works with or without irinotecan hydrochloride as second-line therapy in treating patients with metastatic colorectal cancer.
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Metastatic disease
- Biopsy of either the primary cancer or metastatic site required
- Tumor expressing wild-type Kras mutations
- Progressive disease within 3 months after treatment with first-line fluorouracil (5-FU) and oxaliplatin-based chemotherapy OR evidence of metastatic disease within 6 months of completing adjuvant therapy with 5-FU and oxaliplatin
- Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR as ≥ 10 mm with spiral CT scan
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 6 months
- ANC > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hemoglobin ≥ 9 g/dL
- Creatinine < 1.5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN (or < 2 mg/dL)
- AST and/or ALT < 3 times ULN (< 5 times ULN with liver metastases)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No concurrent malignancy requiring therapy except minor surgery for non-melanoma skin cancer removal
- No interstitial lung disease with symptoms (e.g., dyspnea or cough) including any of the following significant conditions:
- Parenchymal lung disease
- Metastatic disease
- Pulmonary infections
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior EGFR inhibitors, irinotecan hydrochloride, or other second-line chemotherapy regimens
- More than 4 weeks since prior radiotherapy
- No other concurrent investigational agents
- No other concurrent anticancer treatment modalities (e.g., radiotherapy)
Data sourced from ClinicalTrials.gov (NCT00940316). 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.