Impact of an Oncology Clinical Pharmacist Intervention on Clinical Trial Enrollment in The US Oncology Network's MYLUNG Consortium.

Introduction: The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium™ (MYLUNG) clinical trial platform aims to advance the use of precision medicine in patients with non-small cell lung cancer through a series of prospective and iterative clinical trials. Timely patient accrual onto oncology clinical trials is a known practice challenge and impaired accrual rates can lead to premature trial closure or properly powered trial outcomes. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) initiative to provide remote clinical services to screen patients for enrollment onto MYLUNG Protocol 2.

Paclitaxel, 5-fluorouracil, and leucovorin (TFL) in the treatment of metastatic breast cancer.

To assess the activity of paclitaxel in combination with 5-fluorouracil (5-FU) and leucovorin in breast cancer, a phase II trial was conducted in women with metastatic disease. Toxicity, response rate, median survival, median duration of response, and median time to disease progression were measured. Between January 1994 and May 1996, 47 patients with metastatic breast cancer and an Eastern Cooperative Oncology Group (ECOG) performance status (PS) < or = 2 who had previously been treated with chemotherapy received 175 mg/m2 paclitaxel over 3 hours on day 1.

Oral ondansetron 8 mg twice daily is as effective as 8 mg three times daily in the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. S3A-376 Study Group.

The efficacy and safety of ondansetron 8 mg BID compared with 8 mg TID for 3 days in the prevention of nausea and vomiting in 402 patients on cyclophosphamide (> or = 500 mg/m2)-based chemotherapy were evaluated in a multicenter, randomized, double-blind, stratified study. The percentage of patients with no emetic episodes over the 3-day study period was 61% in the ondansetron BID group compared with 58% in the ondansetron TID group. Among patients with at least one emetic episode, the mean time to emesis was 14 hr and 17 min in the ondansetron BID group compared with 12 hr and 48 min in the ondansetron TID group.

Paclitaxel and 5-fluorouracil in metastatic breast cancer: the US experience.

Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is an effective drug in the treatment of metastatic breast cancer (MBC). In the salvage setting, 5-fluorouracil (5-FU) and folinic acid have proved to be effective against MBC as well. Recent preclinical data suggest that paclitaxel plus 5-FU has additive cytotoxicity.

Efficacy of oral ondansetron, a selective antagonist of 5-HT3 receptors, in the treatment of nausea and vomiting associated with cyclophosphamide-based chemotherapies. Ondansetron Study Group.

We evaluated the efficacy and safety of oral ondansetron, a selective antagonist of 5-HT3 receptors, for the treatment of nausea and vomiting associated with cyclophosphamide-based chemotherapy (> 500 mg/m2). In this trial 324 chemotherapy-naive cancer patients, mostly females with breast cancer, were randomized to receive either placebo or ondansetron 1 mg, 4 mg, or 8 mg three times per day for 3 days. There were no differences in the doses of cyclophosphamide, doxorubicin, and methotrexate between the study groups.

Results of a compassionate-use program using intravenous ondansetron to prevent nausea and vomiting in patients receiving emetogenic cancer chemotherapy.

This study reports the effectiveness and side effects of intravenous ondansetron as a single-agent antiemetic therapy for patients receiving emetogenic cancer chemotherapy under a compassionate-use program for patients not enrolled in controlled clinical trials. Patients were > or = 7 years old and had uncontrolled nausea and vomiting or intolerable side effects with standard antiemetics administered with previous cancer chemotherapy. All patients received ondansetron 0.

Phase I trial of mitoxantrone by 24-hour continuous infusion.

Mitoxantrone (DAD) is a new agent which intercalates into DNA. Preclinical studies have demonstrated activity equal to or greater than that of doxorubicin in all tumor systems tested. In this phase I clinical trial, the schedule of drug administration consisted of a 24-hour continuous iv infusion repeated at 21-day intervals.

Cryosurgery in cutaneous leishmaniasis.

Thirty patients with cutaneous leishmaniasis were treated with cryotherapy using a CO2 cryomachine and all were cured without noticeable scarring within 4-5 weeks, with no relapse. Histopathological examination showed that cryotherapy eradicated all parasites in less than 1 hour. Leishmania tropica, L.

Phase II trial of combination therapy with continuous-infusion PALA and bolus-injection 5-FU.

Fifty-seven patients were treated with continuous infusion of PALA at a dose of 850 mg/m2/day x 5 and iv bolus injection of 5-FU at a dose of 300 mg/m2/day x 5, which was given at the end of each 24-hour PALA infusion; the treatment interval was 28 days. The overall response rate among 43 evaluable patients was 14%. Two of 21 patients (10%) with colorectal carcinoma, two of eight patients with pancreatic carcinoma, and two of four patients with breast carcinoma achieved partial responses lasting 2-12 months.

A phase I trial of combination therapy with continuous-infusion PALA and continuous-infusion 5-FU.

Thirty-four patients were treated with N-(phosphonacetyl)-L-aspartate (PALA) at a dose of 850 mg/m2/day x 5 by continuous intravenous infusion (days 1-5) and 5-fluorouracil (5-FU) on an escalating dose schedule of 300-630 mg/m2/day x 5 by continuous intravenous infusion (days 2-6). Dose-limiting oral mucositis occurred at a 5-FU dose of 560 mg/m2/day; other toxicities included nausea, vomiting, diarrhea, skin rash, and superficial venous phlebitis. Myelosuppression was rare.

Treatment of advanced squamous cell carcinoma of the head and neck with cisplatin, bleomycin, and methotrexate (PBM).

Twenty-nine of 32 patients with advanced squamous cell carcinoma of the head and neck were treated with two courses of an intensive chemotherapy regimen consisting of cisplatin, bleomycin, and methotrexate (PBM). The frequency of toxic effects (in 29 evaluable patients) associated with this regimen was low. Serious neutropenia occurred in 17% and thrombocytopenia in 10% of the courses.

Chemotherapy for advanced carcinoma of the head and neck. A clinical update.

Optimal therapy for stage III and stage IV squamous carcinoma arising in the head and neck requires a multidisciplinary approach, including chemotherapy. Advances have identified several chemotherapeutic agents and combinations of agents that show substantial antitumor activity in this disease. While antitumor activity can be documented, experience indicates the duration of antitumor effect is short, and the toxicity may limit further therapy.

Phase I trial of combination therapy with PALA and 5-FU.

PALA is an inhibitor of de novo pyrimidine biosynthesis. Studies combining PALA with 5-FU in experimental models have demonstrated synergistic antitumor activity with only additive toxicity. The phase I study of PALA in combination with 5-FU is described.

Phase I trial of N-(Phosphonacetyl)-L-aspartic acid (PALA).

N-(Phosphonacetyl)-L-aspartic acid (PALA) was given as a 5-day continuous infusion in a phase I trial. Dose-limiting toxic effects noted were diarrhea occurring at doses of greater than or equal to 6 g/m2/course, mucositis occurring at doses of greater than or equal to 7.5 g/m2/course, and skin rash occurring at doses greater than 9 g/m2/course.