29 research outputs found
Phase II Trial with Carboplatin and Bendamustine in Patients with Extensive Stage Small-Cell Lung Cancer
Background:Bendamustine is an alkylating agent with hybrid activity and proven efficacy in small-cell lung cancer associated with a favorable toxicity rate. This phase II study of carboplatin/bendamustine was conducted to evaluate the efficacy of this combination in patients with extensive disease small-cell lung cancer (ED-SCLC).Methods:Fifty-six untreated patients with ED-SCLC were enrolled. Their median age was 63 years. Sixty-seven percent of patients were male and 18% had a World Health Organization performance status of 2. Bendamustine was administered as a 30- to 60-minute infusion at a dose of 80 mg/m2 on days 1 and 2, and carboplatin was given at an area under the curve of 5 on day 1 of a 21-day cycle.Results:Fifty-five patients were assessable for response and toxicity. The overall response rate was 72.7% (95% confidence interval: 59%–84%), with one complete remission (1.8%). The median time to progression was 5.2 months (95% confidence interval: 4.2–5.6). At the time of evaluation, 71% of the patients had died. The median survival time reached 8.3 months (95% confidence interval: 6.6–9.9). The major toxicity of this regimen was myelosuppression, including grade 3 or 4 neutropenia (46%), thrombopenia (26%), anemia (15%), and infections (11%). Toxic death was recorded in two patients (3.6%).Conclusions:The carboplatin/bendamustine regimen is a well-tolerated cytostatic combination in ED-SCLC with activity comparable with that of other platinum-based regimens. Further investigations, such as a phase III trial, are currently planned
a randomized, placebo-controlled phase II AIO trial with serum biomarker program
Background As a multi-targeted anti-angiogenic receptor tyrosine kinase (RTK)
inhibitor sunitinib (SUN) has been established for renal cancer and
gastrointestinal stromal tumors. In advanced refractory esophagogastric cancer
patients, monotherapy with SUN was associated with good tolerability but
limited tumor response. Methods This double-blind, placebo-controlled,
multicenter, phase II clinical trial was conducted to evaluate the efficacy,
safety and tolerability of SUN as an adjunct to second and third-line FOLFIRI
(NCT01020630). Patients were randomized to receive 6-week cycles including
FOLFIRI plus sodium folinate (Na-FOLFIRI) once every two weeks and SUN or
placebo (PL) continuously for four weeks followed by a 2-week rest period. The
primary study endpoint was progression-free survival (PFS). Preplanned serum
analyses of VEGF-A, VEGF-D, VEGFR2 and SDF-1α were performed retrospectively.
Results Overall, 91 patients were randomized, 45 in each group (one patient
withdrew). The main grade ≥3 AEs were neutropenia and leucopenia, observed in
56 %/20 % and 27 %/16 % for FOLFIRI + SUN/FOLFIRI + PL, respectively. Median
PFS was similar, 3.5 vs. 3.3 months (hazard ratio (HR) 1.11, 95 % CI
0.70–1.74, P = 0.66) for FOLFIRI + SUN vs. FOLFIRI + PL, respectively. For
FOLFIRI + SUN, a trend towards longer median overall survival (OS) compared
with placebo was observed (10.4 vs. 8.9 months, HR 0.82, 95 % CI 0.50–1.34,
one-sided P = 0.21). In subgroup serum analyses, significant changes in VEGF-A
(P = 0.017), VEGFR2 (P = 0.012) and VEGF-D (P < 0.001) serum levels were
observed. Conclusions Although sunitinib combined with FOLFIRI did not improve
PFS and response in chemotherapy-resistant gastric cancer, a trend towards
better OS was observed. Further biomarker-driven studies with other anti-
angiogenic RTK inhibitors are warranted. Trial registration This study was
registered prospectively in the NCT Clinical Trials Registry
(ClinicalTrials.gov) under NCT01020630 on November 23, 2009 after approval by
the leading ethics committee of the Medical Association of Rhineland-
Palatinate, Mainz, in coordination with the participating ethics committees
(see Additional file 2) on September 16, 2009
Changes in VEGF-A-serum levels after DEBIRI-TACE in patients with liver metastases of chemorefractory colorectal cancer.
Phase I Study of a Weekly Schedule of Irinotecan, High-Dose Leucovorin, and Infusional Fluorouracil as First-Line Chemotherapy in Patients With Advanced Colorectal Cancer
Induction chemotherapy followed by concurrent chemotherapy and high-dose radiotherapy for locally advanced squamous cell carcinoma of the cervical oesophagus
Gastrointestinal tract cancer liaison office: An attempt to organise clinical research in europe
The Gastrointestinal Tract Cancer Liaison Office (GITCLO) was developed in an attempt to organise the increasing body of clinical research in gastrointestinal tumours in Europe. This paper represents an analysis, by tumour localisation, of the trials collected for the second edition of the GITCLO booklet. The list of co-operative groups, chairmen and study co- ordinators is given with their respective telephone and telefax numbers. A total of 84 trials were collected, conducted by 46 co-operative groups in 14 countries. For each organ and stage of disease, a summary of concepts investigated is given with the references of the study co-ordinator. Obviously, too many questions are raised at the same time. In colorectal cancer, for example, a total of 41 trials exploring 22 concepts are currently open for patients' registration. We hope that the present attempt to clarify the situation of clinical research in the field of gastrointestinal cancers in Europe will speed up therapeutic progress in the best interest of the patients.SCOPUS: ar.jinfo:eu-repo/semantics/publishe