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Randomized phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant.
J Clin Oncol. 2003 Apr 15; 21(8):1452-8.JC

Abstract

PURPOSE

To evaluate the safety of recombinant human keratinocyte growth factor (KGF) when administered with fluorouracil (FU) in patients with metastatic colorectal cancer.

PATIENTS AND METHODS

Patients (N = 81) received KGF by intravenous (IV) bolus on days 1 to 3, followed by FU 425 mg/m2/d IV bolus plus leucovorin 20 mg/m2/d IV on days 4 to 8. KGF dose levels were 1, 10, 20, 40, 60, and 80 microg/kg/d. A randomized, placebo-controlled design was employed (2:1 randomization of KGF to placebo). Oral mucositis was assessed by examination on days 1, 4, 8, 15, and 28. In addition, patients provided daily assessments of oral symptoms using a self-administered questionnaire.

RESULTS

Skin and oral events occurred in 13 of 18 patients (eight patients, grade 1; four patients, grade 2; and one patient, grade 3) treated with 60 and 80 microg/kg of KGF and three of 11 patients treated with 40 microg/kg (grade 1). These symptoms were dose limiting in three cases (ie, in two of 10 patients treated with 80 microg/kg and in one of eight patients treated with 60 microg/kg). The frequency of grade 2 to 4 mucositis was 43% in patients treated with KGF, compared with 67% in patients treated with placebo (P =.06). Patient self-assessments of oral pain and clinical assessments of mucositis showed good correlation (Kendall's tau = 0.75).

CONCLUSION

KGF is generally well tolerated when administered IV at doses up to 40 microg/kg/d for 3 days before a 5-day course of FU plus leucovorin. A clinically meaningful biologic effect was also suggested in that patients treated with the epithelial growth factor KGF had a lower rate of grade 2 to 4 mucositis than did patients treated with placebo.

Authors+Show Affiliations

Fox Chase Cancer Center, 7701 Burholme Ave, Philadelphia, PA 19111, USA. nj_meropol@fccc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12697866

Citation

Meropol, Neal J., et al. "Randomized Phase I Trial of Recombinant Human Keratinocyte Growth Factor Plus Chemotherapy: Potential Role as Mucosal Protectant." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 21, no. 8, 2003, pp. 1452-8.
Meropol NJ, Somer RA, Gutheil J, et al. Randomized phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant. J Clin Oncol. 2003;21(8):1452-8.
Meropol, N. J., Somer, R. A., Gutheil, J., Pelley, R. J., Modiano, M. R., Rowinsky, E. K., Rothenberg, M. L., Redding, S. W., Serdar, C. M., Yao, B., Heard, R., & Rosen, L. S. (2003). Randomized phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 21(8), 1452-8.
Meropol NJ, et al. Randomized Phase I Trial of Recombinant Human Keratinocyte Growth Factor Plus Chemotherapy: Potential Role as Mucosal Protectant. J Clin Oncol. 2003 Apr 15;21(8):1452-8. PubMed PMID: 12697866.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized phase I trial of recombinant human keratinocyte growth factor plus chemotherapy: potential role as mucosal protectant. AU - Meropol,Neal J, AU - Somer,Robert A, AU - Gutheil,John, AU - Pelley,Robert J, AU - Modiano,Manuel R, AU - Rowinsky,Eric K, AU - Rothenberg,Mace L, AU - Redding,Spencer W, AU - Serdar,Cuneyt M, AU - Yao,Bin, AU - Heard,Robert, AU - Rosen,Lee S, PY - 2003/4/17/pubmed PY - 2003/5/6/medline PY - 2003/4/17/entrez SP - 1452 EP - 8 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 21 IS - 8 N2 - PURPOSE: To evaluate the safety of recombinant human keratinocyte growth factor (KGF) when administered with fluorouracil (FU) in patients with metastatic colorectal cancer. PATIENTS AND METHODS: Patients (N = 81) received KGF by intravenous (IV) bolus on days 1 to 3, followed by FU 425 mg/m2/d IV bolus plus leucovorin 20 mg/m2/d IV on days 4 to 8. KGF dose levels were 1, 10, 20, 40, 60, and 80 microg/kg/d. A randomized, placebo-controlled design was employed (2:1 randomization of KGF to placebo). Oral mucositis was assessed by examination on days 1, 4, 8, 15, and 28. In addition, patients provided daily assessments of oral symptoms using a self-administered questionnaire. RESULTS: Skin and oral events occurred in 13 of 18 patients (eight patients, grade 1; four patients, grade 2; and one patient, grade 3) treated with 60 and 80 microg/kg of KGF and three of 11 patients treated with 40 microg/kg (grade 1). These symptoms were dose limiting in three cases (ie, in two of 10 patients treated with 80 microg/kg and in one of eight patients treated with 60 microg/kg). The frequency of grade 2 to 4 mucositis was 43% in patients treated with KGF, compared with 67% in patients treated with placebo (P =.06). Patient self-assessments of oral pain and clinical assessments of mucositis showed good correlation (Kendall's tau = 0.75). CONCLUSION: KGF is generally well tolerated when administered IV at doses up to 40 microg/kg/d for 3 days before a 5-day course of FU plus leucovorin. A clinically meaningful biologic effect was also suggested in that patients treated with the epithelial growth factor KGF had a lower rate of grade 2 to 4 mucositis than did patients treated with placebo. SN - 0732-183X UR - https://www.unboundmedicine.com/medline/citation/12697866/Randomized_phase_I_trial_of_recombinant_human_keratinocyte_growth_factor_plus_chemotherapy:_potential_role_as_mucosal_protectant_ L2 - https://ascopubs.org/doi/10.1200/JCO.2003.10.079?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -