A randomized phase III trial of combined paclitaxel, carboplatin, and radiation therapy followed by weekly paclitaxel or observation for patients with locally advanced inoperable non-small-cell lung cancer.

Background: This study was designed to determine the efficacy and safety of additional maintenance chemotherapy after standard induction chemotherapy/radiation therapy (XRT) in stage III non-small-cell lung cancer (NSCLC). The primary objective was to increase 1-year survival.

Patients And Methods: Eligible patients (N = 220) had confirmed stage IIIA or IIIB NSCLC, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

The effect of tamoxifen or exemestane on bone mineral density during the first 2 years of adjuvant treatment of postmenopausal women with early breast cancer.

Background: Adjuvant therapy with aromatase inhibitors is associated with increased bone loss in postmenopausal women with breast cancer. We assessed changes in bone mineral density (BMD) from baseline to 24 months in patients receiving either tamoxifen (T) or exemestane (E).

Patients And Methods: A total of 578 women randomly assigned to T 20 mg per day orally or E 25 mg/day orally enrolled in this substudy; baseline, 12-month, and 24-month BMD measurements of the femur and lumbar spine by dual-energy x-ray absorptiometry were planned.

Favorable survival observed after carboplatin, paclitaxel, and concurrent accelerated hyperfractionated radiotherapy for treatment of locally advanced head and neck carcinoma.

Purpose: Several trials have demonstrated the superiority of simultaneous chemoradiotherapy compared with radiation alone for patients with locally advanced head and neck cancers. However, the optimal regimen remains to be defined. This study assessed the safety and activity of combined carboplatin (C), paclitaxel (P), and twice-daily radiotherapy (RT) in a community based, multicenter, phase II trial.

A phase II study of pemetrexed in patients with advanced hepatocellular carcinoma.

Pemetrexed has demonstrated activity in hepatocellular carcinoma (HCC) cell lines, and has a manageable toxicity profile in clinical trials, suggesting its potential as a treatment for HCC patients. A multicenter, Phase II community-based study was conducted to assess the response rate and toxicity profile of single-agent pemetrexed in first-line patients with advanced or metastatic HCC. Patients premedicated with folic acid, vitamin B(12), and dexamethasone were administered pemetrexed 600 mg/m(2) IV on day 1 of each 21-day cycle until disease progression.

Phase I study of a 3-drug regimen of gemcitabine/cisplatin/pemetrexed in patients with metastatic transitional cell carcinoma of the urothelium.

Objectives: Gemcitabine (G) plus cisplatin (C) is standard care for metastatic transitional cell carcinoma (TCC) of the urothelium. Pemetrexed (P), alone or in combination with G, is active in metastatic TCC. However, the safety and efficacy of P combined with GC therapy is unknown.

Comparison of menopausal symptoms during the first year of adjuvant therapy with either exemestane or tamoxifen in early breast cancer: report of a Tamoxifen Exemestane Adjuvant Multicenter trial substudy.

Purpose: Hormonal breast cancer treatment increases menopausal symptoms in women. This study investigated differences between the symptoms associated with either adjuvant tamoxifen or exemestane.

Patients And Methods: Ten common symptoms were assessed by self-report questionnaire administered to 1,614 consecutive patients at baseline and every 3 months during the first year of a double-blind, randomized trial of postmenopausal women with early hormone receptor-positive breast cancer.

Phase II trial of capecitabine and weekly paclitaxel in patients with metastatic breast cancer previously treated with every-3-week taxane therapy.

Purpose: We conducted a multicenter phase II trial to determine the efficacy/safety of capecitabine and weekly paclitaxel, a combination with preclinical evidence of synergy, in patients with metastatic breast cancer (MBC) previously treated with a taxane.

Patients And Methods: Eligibility criteria included measurable MBC, history of every-3-week taxane therapy (adjuvant or for MBC), and no previous taxane on a weekly basis, capecitabine, or infusional 5-fluorouracil. Patients received capecitabine 825 mg/m2 per dose orally twice daily (1650 mg/m2 per day) on days 1-14 and weekly paclitaxel 80 mg/m2 intravenously on days 1 and 8, followed by a 1-week rest period (every-3-week cycle) until progression or intolerable toxicity.

Phase II Trial of a Novel Paclitaxel Schedule As Single-Agent, First-Line Therapy for HER-2/neu-Negative Metastatic Breast Cancer: A Community-Based Study.

Purpose: To determine the response rate (RR), progression-free survival (PFS), and toxicity in patients with HER-2/neu-negative metastatic breast cancer treated with first-line paclitaxel in a de-escalating dosing schedule.

Patients And Methods: Between August 1999 and December 2000, 73 patients were enrolled. Paclitaxel was administered on day 1 (175 mg/m(2)) and on days 8 and 15 (80 mg/m(2) each) in each 4-week cycle (1 week of rest).

Phase II trial of docetaxel/capecitabine in hormone-refractory prostate cancer.

Background: Docetaxel is the most active single agent in the treatment of hormone-refractory prostate cancer (HRPC). Because of the preclinical and clinical evidence of synergy of capecitabine and docetaxel, it was hypothesized that this combination would be active and tolerable in HRPC.

Patients And Methods: Patients received docetaxel 60 mg/m2 intravenously over 60 minutes on day 1 of each 21-day cycle and capecitabine 1000 mg/m2 administered orally twice daily on days 1-14 of each cycle for a maximum of 8 cycles or until disease progression or intolerable toxicity.

A phase II study of weekly paclitaxel/estramustine/carboplatin in hormone-refractory prostate cancer.

Purpose: The objective of this phase II study was to determine the response rate in patients with hormone-refractory prostate cancer given paclitaxel/estramustine/carboplatin for weeks 1, 2, and 3 of a 4-week cycle.

Patients And Methods: Eighty-four patients were registered into the trial. Paclitaxel 80 mg/m2 and carboplatin area under the curve of 2 were administered intravenously on days 2, 9, and 16, and oral estramustine 280 mg 3 times daily was given on days 1-3, 8-10, and 15-17 for 6 cycles.

Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer.

Purpose: The taxanes and capecitabine have synergistic antitumor activity in preclinical models. This trial was designed to determine the efficacy and tolerability of weekly paclitaxel plus capecitabine as first-line treatment for metastatic breast cancer (MBC).

Patients And Methods: Participants had histologically proven breast cancer, with measurable metastatic disease by Response Evaluation Criteria in Solid Tumors Group.

Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2-overexpressing metastatic breast cancer.

Purpose: This randomized, multicenter, phase III trial evaluated the efficacy and safety of trastuzumab and paclitaxel with or without carboplatin as first-line therapy for women with HER-2-overexpressing metastatic breast cancer (MBC).

Patients And Methods: HER-2 overexpression was defined as immunohistochemical staining scores of 2+ or 3+. Between November 1998 and May 2002, 196 women with HER-2-overexpressing MBC were randomly assigned to six cycles of either trastuzumab 4 mg/kg loading dose plus 2 mg/kg weekly thereafter with paclitaxel 175 mg/m2 every 3 weeks (TP), or trastuzumab 4 mg/kg loading dose plus 2 mg/kg weekly thereafter with paclitaxel 175 mg/m2 and carboplatin area under the time-concentration curve = 6 every 3 weeks (TPC) followed by weekly trastuzumab alone.

Results of a Phase II study of weekly docetaxel and carboplatin in Stage IIIB (with effusion) or Stage IV non-small cell lung cancer patients age

This study explores if advanced NSCLC patients with ECOG PS 2 and age View Article and Find Full Text PDF

Phase II trial of weekly docetaxel/ gemcitabine as first-line chemotherapy in patients with locally recurrent or metastatic breast cancer.

Purpose: A phase II study evaluated weekly docetaxel/gemcitabine as first-line chemotherapy for locally recurrent or metastatic breast cancer in a multicenter community oncology practice setting.

Patients And Methods: Eligible patients who had not received chemotherapy for metastatic disease received docetaxel 30 mg/m2 followed by gemcitabine 800 mg/m2, each administered weekly for 3 weeks (days 1, 8, and 15), followed by a 1-week rest period (28-day cycle). Patients also received oral dexamethasone to reduce the incidence/severity of fluid retention and hypersensitivity reactions.

Results of a Phase II study of carboplatin plus gemcitabine in patients with untreated extensive small cell lung cancer.

Purpose: To determine the response rate (RR) and survival produced by carboplatin + gemcitabine therapy in patients with untreated extensive small cell lung cancer (ESCLC).

Patients And Methods: Treatment consisted of carboplatin (AUC = 5) on day 1 and gemcitabine (1100 mg/m(2)) on days 1 and 8 of each 21-day cycle for 4 planned cycles (additional cycles allowed as per treating physician). ECOG performance status 0/1/2 was 29, 58, and 13%.

Results of a phase II study of weekly paclitaxel plus carboplatin in patients with extensive small-cell lung cancer with Eastern Cooperative Oncology Group Performance Status of 2, or age > or = 70 years.

Purpose: To determine the 1-year survival, response rate (RR), time to progression (TTP), and safety of weekly paclitaxel plus carboplatin (PC) in patients with extensive small-cell lung cancer (ESCLC) with an Eastern Cooperative Performance Status performance status (PS) of 2 or an age > or = 70 years.

Patients And Methods: Patients were treated with PC (paclitaxel 80 mg/m(2) and carboplatin area under the curve = 2) by intravenous infusion on days 1, 8, and 15 of every 4-week cycle for up to six cycles.

Results: Between July 2000 and December 2001, 77 eligible patients (50.