Phase I Study of Conformal Radiotherapy and Concurrent Full-Dose Gemcitabine With Erlotinib for Unresected Pancreatic Cancer

Journal Article · Wed Feb 01 04:00:00 EST 2012 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/J.IJROBP.2010.08.050· OSTI ID:22056036

Margolis, Jeffrey ^[1]; Jury, Robert P ^[2]; Balaraman, Savitha; Cotant, Matthew B; Ballouz, Samer; Boxwala, Iqbal G; Jaiyesimi, Ishmael A; Nadeau, Laura ^[1]; Hardy-Carlson, Maria ^[3]; Marvin, Kimberly S; Wallace, Michelle; Hong, Ye ^[4]

---

1. Division of Medical Oncology, William Beaumont Hospital, Royal Oak, MI (United States)
2. Department of Surgery, William Beaumont Hospital, Royal Oak, MI (United States)
3. Division of Radiation Oncology, M. D. Anderson Cancer Center, Houston, TX (United States)
4. Department of Radiation Oncology, William Beaumont Hospital, Royal Oak, MI (United States)

Purpose: To determine the recommended dose of radiotherapy when combined with full-dose gemcitabine and erlotinib for unresected pancreas cancer. Methods and Materials: Patients with unresected pancreatic cancer (Zubrod performance status 0-2) were eligible for the present study. Gemcitabine was given weekly for 7 weeks (1,000 mg/m{sup 2}) with erlotinib daily for 8 weeks (100 mg). A final toxicity assessment was performed in Week 9. Radiotherapy (starting at 30 Gy in 2-Gy fractions, 5 d/wk) was given to the gross tumor plus a 1-cm margin starting with the first dose of gemcitabine. A standard 3 plus 3 dose escalation (an additional 4 Gy within 2 days for each dose level) was used, except for the starting dose level, which was scheduled to contain 6 patients. In general, Grade 3 or greater gastrointestinal toxicity was considered a dose-limiting toxicity, except for Grade 3 anorexia or Grade 3 fatigue alone. Results: A total of 20 patients were treated (10 men and 10 women). Nausea, vomiting, and infection were significantly associated with the radiation dose (p = .01, p = .03, and p = .03, respectively). Of the 20 patients, 5 did not complete treatment and were not evaluable for dose-escalation purposes (3 who developed progressive disease during treatment and 2 who electively discontinued it). Dose-limiting toxicity occurred in none of 6 patients at 30 Gy, 2 of 6 at 34 Gy, and 1 of 3 patients at 38 Gy. Conclusion: The results of the present study have indicated that the recommended Phase II dose is 30 Gy in 15 fractions.

• OSTI ID: 22056036
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 2 Vol. 82; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
ANOREXIA
FATIGUE
MEN
NAUSEA
NEOPLASMS
PANCREAS
PATIENTS
PERFORMANCE
RADIATION DOSES
RADIOTHERAPY
TOXICITY
VOMITING
WOMEN