Gemcitabine in the second-line therapy of patients with carcinoma of unknown primary site: a phase II trial of the Minnie Pearl Cancer Research Network.

The purpose of this study was to evaluate the activity of single-agent gemcitabine in previously treated patients with carcinoma of unknown primary site. Between January 1997 and October 1998, 39 patients were enrolled in this multicenter Phase II trial performed in the Minnie Pearl Cancer Research Network. Twenty-seven patients (69%) had adenocarcinoma or poorly differentiated adenocarcinoma; 35 patients (90%) had previously received treatment with chemotherapy regimens containing both a platinum agent and a taxane.

Carcinoma of unknown primary site.

Background: The long term survival and toxicity associated with the chemotherapy combination of paclitaxel, carboplatin, and extended-schedule etoposide used for the treatment of patients with metastatic carcinoma of unknown primary site were evaluated.

Methods: Seventy-one patients were treated between March 1995 and November 1996 with paclitaxel, carboplatin, and oral etoposide every 21 days. Stable or responding patients received four to eight courses of therapy.

Paclitaxel, carboplatin, and vinorelbine in the treatment of advanced non-small cell lung cancer: a phase II trial of the Minnie Pearl Cancer Research Network.

Purpose: To evaluate the feasibility, toxicity, and efficacy of adding vinorelbine to the paclitaxel/carboplatin combination in the treatment of advanced non-small cell lung cancer.

Patients And Methods: Patients with advanced (stage IIIB/IV) non-small cell lung cancer who had received no previous chemotherapy were treated with the following three-drug regimen: paclitaxel, 200 mg/m2, 1-hour i.v.

Carcinoma of unknown primary site: phase II trials with docetaxel plus cisplatin or carboplatin.

Purpose: To evaluate the toxicity, response rate and short-term survival associated with the chemotherapy combinations of docetaxel plus cisplatin or carboplatin when used for the treatment of patients with metastatic carcinoma of unknown primary site.

Patients And Methods: Twenty-six patients were treated with docetaxel 75 mg/m2 i.v.

Paclitaxel-based therapy in non-small-cell lung cancer: improved third generation chemotherapy.

The newer or 'third generation' chemotherapeutic agents (paclitaxel, docetaxel, vinorelbine, gemcitabine, irinotecan, topotecan) have all recently been shown to have substantial activity against non-small-cell lung cancer (NSCLC). Many of these agents are now being incorporated into the therapy for patients with advanced disease. Paclitaxel was the first 'third generation' drug to be studied.

Weekly administration of docetaxel (Taxotere): summary of clinical data.

Docetaxel (Taxotere; Rhône-Poulence Rorer, Antony, France) is a highly efficacious antineoplastic agent; however, its administration every 3 weeks produces substantial myelosuppression. Based on recent observations that the administration of paclitaxel on a weekly schedule minimizes myelosuppression, investigation of weekly docetaxel has been initiated. A recently completed phase I study of weekly docetaxel demonstrates markedly decreased myelosuppression with this schedule.

One-hour paclitaxel infusions: review of safety and efficacy.

Purpose: Paclitaxel has emerged as one of the most active anticancer agents in clinical oncology. Hypersensitivity reactions encountered in the clinical development of this drug prompted the implementation of premedication regimens and prolonged infusions, later amended to a 3-hour infusion schedule. Now that paclitaxel is frequently used in outpatient therapy, optimum efficiency in delivery is an issue.

The evolving role of paclitaxel for patients with carcinoma of unknown primary site.

Patients with carcinoma of unknown primary site represent a very heterogeneous clinicopathologic group. Progress has been made in defining important clinical subsets, and specialized pathologic analysis is essential for the poorly differentiated neoplasms. Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is a broad-spectrum antineoplastic agent with demonstrated activity in a wide variety of carcinomas.

The current role and future prospects of paclitaxel in the treatment of small cell lung cancer.

When combination regimens containing a platinum compound and etoposide are used, median survivals in patients with extensive- and limited-stage small cell lung cancer are 7 to 10 months and 15 to 20 months, respectively. A recent randomized trial demonstrated equivalent efficacy and decreased toxicity with carboplatin/etoposide compared with cisplatin/etoposide. Because of excellent single-agent activity, paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) has been recently added to various platinum/etoposide combinations.

Phase I/II trial of paclitaxel by 1-hour infusion, carboplatin, and gemcitabine in the treatment of patients with advanced nonsmall cell lung carcinoma.

Background: The combination of paclitaxel and carboplatin is widely used in the treatment of patients with advanced nonsmall cell lung carcinoma. In this Phase I/II study the authors evaluated the feasibility, toxicity, and efficacy of adding a third active antineoplastic agent, gemcitabine, to the paclitaxel/carboplatin combination for the treatment of patients with advanced nonsmall cell lung carcinoma.

Methods: Patients with advanced (AJCC Stage IIIB or IV) nonsmall cell lung carcinoma previously untreated with chemotherapy were eligible for this trial.

Phase I trial of paclitaxel, carboplatin, and topotecan with or without filgrastim (granulocyte-colony stimulating factor) in the treatment of patients with advanced, refractory cancer.

Background: Topotecan is a new antineoplastic agent with a broad spectrum of activity. The purpose of this Phase I trial was to define the maximum tolerated dose of topotecan when added to the widely used combination of paclitaxel and carboplatin.

Methods: Patients with advanced cancer that was refractory or resistant to standard treatments were treated with paclitaxel, carboplatin, and topotecan; doses were escalated in sequential cohorts of patients.

One-hour paclitaxel plus carboplatin in the treatment of advanced non-small cell lung cancer: results of a multicentre, phase II trial.

The aim of this phase II study was to determine the activity and toxicity of paclitaxel (administered by 1-h infusion) and carboplatin in advanced non-small cell lung cancer when used in a multicentre, community-based treatment setting. 100 chemotherapy-naive patients with stage IIIB or IV non-small cell lung cancer were treated between March 1995 and February 1996. All patients had Karnofsky performance status 70-100, measurable disease and adequate bone marrow, kidney and liver function.

Phase I trial of docetaxel administered by weekly infusion in patients with advanced refractory cancer.

Purpose: Docetaxel is a highly active antineoplastic agent; however, grade IV leukopenia occurs in the large majority of patients treated with a dose of 100 mg/m2 every 3 weeks. Recent experience with weekly paclitaxel has demonstrated a bone marrow-sparing effect when a weekly administration schedule is used. We investigated a weekly schedule of docetaxel in an attempt to alter the toxicity profile and improve the therapeutic index.

Evolving role of oral chemotherapy for the treatment of patients with neoplasms.

The past 20 years has seen an increasing trend toward the use of oral chemotherapy for the treatment of patients with a variety of malignancies. The advantages of oral chemotherapy include lower treatment cost, compared with that of intravenous (i.v.

One-hour paclitaxel plus carboplatin for advanced non-small-cell lung cancer.

We report here the preliminary results of a large phase II multicenter study done in the community setting, using paclitaxel (Taxol) (given by 1-hour infusion) plus carboplatin (Paraplatin) to treat patients with advanced non-small-cell lung cancer (NSCLC). In this study, 155 chemotherapy-naive patients with stage IIIB, stage IV, or recurrent metastatic non-small-cell lung cancer received the two drugs in 21-day cycles. Paclitaxel 225 mg/m2 was given by 1-hour intravenous infusion followed immediately by carboplatin at a targeted area under the concentration-time curve of 6.

Paclitaxel, carboplatin, and extended-schedule oral etoposide for small-cell lung cancer.

We evaluated the feasibility and efficacy of combination paclitaxel (Taxol) (via 1-hour infusion), carboplatin (Paraplatin), and oral etoposide (VePesid) in the first-line treatment of patients with small-cell lung cancer. Between June 1993 and July 1996, 117 patients with small-cell lung cancer. were treated in two sequential phase II studies.

One-hour paclitaxel, carboplatin, and extended-schedule etoposide in the treatment of carcinoma of unknown primary site.

This phase II study was conducted to evaluate the efficacy and toxicity of a novel chemotherapy combination that included paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), carboplatin, and extended-schedule etoposide for the treatment of patients with carcinoma of unknown primary site. Fifty-five patients were treated with the following regimen, administered every 21 days: paclitaxel 200 mg/m2 by 1-hour intravenous infusion, day 1; carboplatin at an estimated area under the concentration-time curve of 6.0, day 1; and etoposide 50 mg alternating with 100 mg orally, days 1 through 10.

Paclitaxel with mitoxantrone with or without 5-fluorouracil and high-dose leucovorin in the treatment of metastatic breast cancer.

Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is a highly active single agent in the treatment of breast cancer. However, its optimal incorporation into combination regimens awaits definition. We added paclitaxel, administered by 1-hour infusion, to a previously described combination regimen that included mitoxantrone, 5-fluorouracil, and high-dose leucovorin.

Paclitaxel (1-hour infusion) plus carboplatin in the treatment of advanced non-small cell lung cancer: results of a multicenter phase II trial.

This study was performed to determine the activity and toxicity of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) given by 1-hour infusion plus carboplatin in the treatment of patients with advanced non-small cell lung cancer when used in a multicenter, community-based setting. The study population included 100 chemotherapy-naive patientswith stage IIIB or IV non-small cell lung cancer, Karnofsky performance status 70 to 100, measurable disease, and adequate kidney, liver, and bone marrow function. All patients received paclitaxel 225 mg/m2 intravenously by 1-hour infusion followed immediately by carboplatin at a targeted area under the concentration-time curve of 6.

Carcinoma of unknown primary site: treatment with 1-hour paclitaxel, carboplatin, and extended-schedule etoposide.

Purpose: To evaluate the efficacy and toxicity of a novel chemotherapy combination that includes paclitaxel, carboplatin, and extended-schedule etoposide in the treatment of patients with carcinoma of unknown primary tumor site.

Patients And Methods: Fifty-five patients with carcinoma of unknown primary tumor site were treated with the following regimen, administered every 21 days: paclitaxel 200 mg/m2 by 1-hour intravenous (I.V.

Multidisciplinary approach to potentially curable non-small cell carcinoma of the lung.

The management of patients with non-small-cell lung cancer (NSCLC) is still evolving. Newer third-generation chemotherapy (paclitaxel [Taxol]-based; vinorelbine [Navelbine]/ cisplatin [Platinol]) is more effective than second-generation cisplatin-based chemotherapy for patients with stage IIIB and IV disease. The combined use of cisplatin-based chemotherapy with sequential or concurrent radiation therapy has improved the survival of patients with unresectable stage IIIA disease.

Paclitaxel via 1-hour infusion: clinical experience.

In phase II trials, paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) can be safely administered via a 1-hour infusion. One-hour infusions of paclitaxel also have been administered safely in combination with many other cytotoxic regimens, including cisplatin/etoposide/radiation, carboplatin/etoposide (with or without radiation), mitoxantrone/5-fluorouracil/leucovorin, carboplatin, and carboplatin/5-fluorouracil. Notable activity has been seen in patients with several neoplasms, including stages III/IV non-small cell lung cancer, small cell lung cancer, advanced breast cancer, carcinoma of unknown primary site, urothelial carcinomas, and other advanced squamous cell carcinomas.

Paclitaxel, carboplatin, and oral etoposide in the treatment of small cell lung cancer.

Paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) is active in previously untreated patients with small cell lung cancer (SCLC). We evaluated the toxicity and efficacy of a 1-hour infusion of paclitaxel added to a combination regimen of carboplatin and etoposide in a phase II trial for the treatment of patients with SCLC. Thirty-eight patients with previously untreated SCLC were treated with paclitaxel 135 mg/m2 (1-hour intravenous infusion), day 1; carboplatin at area under the concentration-time curve of 5, day 1; and oral etoposide 100 and 50 mg (alternating days), days 1 to 10.

Paclitaxel via 1-hour infusion: rationale and pharmacology.

Although the initial choice to evaluate a 3-hour infusion of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) was arbitrary, the attenuated schedule has since proven safe and active against several neoplasms. Shorter infusions are easier to administer, particularly in combination chemotherapy and combined-modality therapy, prompting our investigations of 1-hour paclitaxel infusions in more than 500 patients and approximately 2,000 treatment courses. The toxicity, activity, and pharmacology of 1- and 3-hour infusions of paclitaxel appear to be similar.

Clinical studies with etoposide phosphate.

Over the past few years we have conducted several clinical studies with etoposide phosphate (Etopophos; Bristol-Myers Squibb Company, Princeton, NJ). A phase I trial initially was performed to determine the maximum tolerated dose and pharmacokinetics. A brief intravenous infusion for 5 consecutive days was given every 3 weeks.