Biomedical subjects

G Thomas Budd

Publications and source records attributed to G Thomas Budd.

5 recordsLinked to original sources

PubMed2003

Phase I trial of weekly docetaxel and gemcitabine in patients with refractory malignancies.

BACKGROUND: A Phase I study using weekly docetaxel and gemcitabine was conducted to investigate toxicity; to determine the maximum tolerated dose (MTD) of each agent; and, in a preliminary fashion, to determine the antitumor activity of the combination. METHODS: Docetaxel and gemcitabine were administered intravenously on Days 1, 8, and 15 every 28 days. The dose levels of docetaxel and gemcitabine were as follows: Level I, docetaxel 20 mg/m(2)and gemcitabine 400 mg/m(2); Level II, docetaxel 30 mg/m(2)and gemcitabine 400 mg/m(2); Level III, docetaxel 30 mg/m(2)and gemcitabine 600 mg/m(2); Level IV, docetaxel 36 mg/m(2)and gemcitabine 600 mg/m(2); and Level V, docetaxel 36 mg/m(2)and gemcitabine 800 mg/m(2). RESULTS: Thirty-three eligible patients were entered. The diagnoses were as follows: Eleven patients had nonsmall cell lung carcinoma, 3 patients had carcinoma of the bladder, 3 patients had renal carcinoma, 2 patients had adrenal carcinoma, 5 patients had unknown primary tumors, and 9 patients had miscellaneous malignancies. Fifty-nine percent of patients had received prior chemotherapy. The median age was 62 years (range, 27-77 years), and the median Eastern Cooperative Oncology Group performance status was 1 (range, 0-1). Five patients were treated at Dose Levels I and II, 6 patients were treated at Dose Levels III and V, and 11 patients were treated at Dose Level IV. Grade 3-4 toxicities during Cycle I included neutropenia, thrombocytopenia, mucositis, and diarrhea. Dose-limiting toxicity, consisting of neutropenia and thrombocytopenia, occurred in three of six patients at Dose Level V. The combination of docetaxel 36 mg/m(2) and gemcitabine 600 mg/m(2) (Dose Level IV) was determined as the MTD and was the recommended Phase II dose. Two patients had a partial response: one patient with bladder carcinoma (Dose Level II) and one patient with nonsmall cell lung carcinoma (Dose Level III). CONCLUSIONS: Overall, weekly docetaxel and gemcitabine were well tolerated. Further studies using this combination are planned, including a Phase II trial in patients with advanced nonsmall cell lung carcinoma.

Adult↗

PubMed2002

Management of angiosarcoma.

Angiosarcoma is an uncommon tumor that presents in several scenarios. Although angiosarcoma can occur in any organ, it typically presents in the following settings: 1) in the face or scalp among elderly patients, 2) with chronic lymphedema, 3) after radiotherapy, or 4) as a hepatic primary. In all of these situations, angiosarcoma is associated with multifocality and an insidious growth pattern, making local control difficult. Doxorubicin-ifosfamide chemotherapy produces a modest response rate, and paclitaxel appears to be useful for scalp and facial angiosarcomas. However, improvement in systemic therapy is clearly needed. One logical strategy is to investigate antiangiogenic therapies in this endothelial tumor. Improved therapy for this tumor will come only with greater understanding of its biology.

Age Factors↗

PubMed2002

Phase II trial of topotecan by continuous infusion in patients with advanced soft tissue sarcomas, a SWOG study. Southwest Oncology Group.

PURPOSE: Based upon the hypothesis that prolonged exposure to the S-Phase specific agent topotecan would be more efficacious in the treatment of soft tissue sarcomas than a conventional 5-day schedule of the drug, the Southwest Oncology Group performed a Phase II trial of topotecan administered as a continuous infusion in adult patients with advanced soft tissue sarcomas. METHODS: Patients who had received no prior chemotherapy for advanced disease were treated with topotecan at a dose of 0.50 mg/m2/day on days 1-21 of repeated 28 day cycles. RESULTS: Twenty-two patients were enrolled on the study, of whom 21 were eligible. No objective responses were observed (95% confidence interval of 0-16%). The median survival was 12 months (95% confidence interval of 5-16 months). CONCLUSIONS: We conclude that topotecan, given either according to a 5-day or a 21-day schedule, has minimal activity in the treatment of adult soft tissue sarcomas.

Adult↗

PubMed2002

Biochemical modulation of 5-fluorouacil through dihydropyrimidine dehydrogenase inhibition: a Southwest Oncology Group phase II trial of eniluracil and 5-fluorouracil in advanced resistant colorectal cancer.

PURPOSE: To investigate the hypothesis that a systemic agent designed to inhibit dihydropyrimidine dehydrogenase (DPD), the first enzyme in the fluoropyrimidine degradative pathway, could improve the effective amount of 5-fluorouracil (5-FU) delivered to a tumor resulting in enhanced response. PATIENTS AND METHODS: Eligibility included cytologically or pathologically verified diagnosis of colorectal cancer that recurred during or within 12 months of completion of adjuvant therapy, representing patients generally considered resistant to fluorinated pyrimidine therapy. Stratification was into two cohorts: recurrence while receiving adjuvant therapy, and relapse within 12 months of completing adjuvant therapy. Treatment consisted of 28 days of oral therapy every five weeks with eniluracil and 5-FU administered in a 10:1 ratio. The daily dose of eniluracil was 10 mg/m2 with 5-FU 1 mg/m2, divided into two doses. RESULTS: Twenty-five patients are evaluable for response: 9 relapsed during therapy and 16 relapsed within one year of adjuvant therapy. In the first group, there was one partial response (9%; 95% CI 0-41%); in the second cohort there was one confirmed complete response (5%; 95% CI 0-23%) and one unconfirmed partial response, for an overall response rate of 10%. CONCLUSIONS: This regimen lacks significant activity in this target population. Pre-treatment intratumoral DPD expression was not assessed, therefore the mechanism of fluorinated pyrimidine resistance cannot be specifically attributed to elevated DPD levels. Attempting restoration of chemotherapy sensitivity through blockade of enzymes or signal transduction molecules responsible for resistance is rational, provided that tumor target expression is the basis for trial entry.

Adult↗

PubMed1999

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Humans↗