Trials / Completed
CompletedNCT00332163
Skin Toxicity Treatment in Metastatic Colorectal Cancer (mCRC) Patients Receiving Panitumumab + Irinotecan-based Therapy
A Phase 2, Open-label, Randomized Clinical Trial of Skin Toxicity Treatment in Subjects Receiving Second-line FOLFIRI or Irinotecan Only Chemotherapy Concomitantly With Panitumumab
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 95 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
A comparison of prophylactic treatment with reactive treatment for skin toxicity observed in patients with metastatic colorectal cancer (mCRC) who are receiving second-line irinotecan-based chemotherapy concomitantly with panitumumab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Panitumumab | Administered by intravenous infusion |
| DRUG | Irinotecan | Recommended dosage regimen and administration of irinotecan was based on local standard of care, the package insert, and institutional guidelines. |
| DRUG | 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. |
| DRUG | Pre-emptive Skin Treatment | Pre-emptive skin treatment included a skin moisturizer (eg, Lubriderm), sunscreen (free of paraaminobenzoic acid (PABA), skin protection factor (SPF) 15 or higher, ultraviolet-A (UV-A), and UV-B protection), topical steroid (1% hydrocortisone cream) and oral antibiotic (doxycycline, 100 mg twice daily). |
| DRUG | Reactive Skin Treatment | Treatment was based on symptoms and severity and may have included an emollient (eg, Lubriderm, Vaseline), sunscreen (SPF ≥ 15), oral antibiotic (eg, doxycycline, ciprofloxacin, cefadroxil, amoxicillin/clavulanic acid), topical steroid (hydrocortisone cream), topical antibiotic (clindamycin), oral systemic steroid, topical medical treatment (eg, silver sulfadiazine, Silvadene), topical antihistamine or oral antihistamine (hydroxyzine) |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2008-01-01
- Completion
- 2008-09-01
- First posted
- 2006-06-01
- Last updated
- 2016-02-23
- Results posted
- 2016-02-23
Source: ClinicalTrials.gov record NCT00332163. Inclusion in this directory is not an endorsement.