Phase II study of gemcitabine in advanced colorectal adenocarcinoma

Moore, Dennis F.; Pazdur, Richard; Daugherty, Karen; Tarassoff, Peter G.; Abbruzzese, James L.

doi:10.1007/bf00944189

Cited by 32 publications

(17 citation statements)

References 14 publications

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“…The incorporation of gemcitabine into DNA increases oxaliplatin binding to DNA, and this may explain the synergistic activity of the combination. In phase II studies of patients with advanced CRC, gemcitabine monotherapy has shown minimal activity [17, 18]. In an attempt to improve treatment results, Mani et al [33] have tested a longer infusion duration of 150 min, but this proved ineffective.…”

Section: Discussionmentioning

confidence: 99%

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Multicenter Phase II Study of Gemcitabine and Oxaliplatin (GEMOX) as Second-Line Chemotherapy in Colorectal Cancer Patients Pretreated with 5-Fluorouracil plus Irinotecan

Ziras

Potamianou²,

Varthalitis³

et al. 2006

Oncology

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Purpose: To evaluate the efficacy and tolerance of the gemcitabine/oxaliplatin (GEMOX) combination as second-line chemotherapy for patients with advanced colorectal cancer (CRC) pretreated with an irinotecan (CPT-11)/5-fluorouracil (5-FU)/leucovorin (LV) regimen. Patients and Methods: Patients with documented disease progression during or after first-line treatment with CPT-11 and 5-FU/LV were enrolled. Gemcitabine (1,000 mg/m² days 1 and 8) and oxaliplatin (100 mg/m² day 1) were administered every 3 weeks. Results: Partialresponses were observed in 6 of the 34 (17.7%) patients enrolled (intention-to-treat analysis; overall response rate: 17.7%; 95% confidence interval 4.8–30.5%). Eight (23.5%) patients experienced disease stabilization and 20 (59%) disease progression (tumor growth control rate = 41.2%). The median duration of response was 5.5 months, and the median time to tumor progression 2.7 months. The median overall survival was 9.1 months (1-year survival rate: 44.0%). Grade 3 neutropenia and thrombocytopenia occurred in 18 and 15% of the patients, respectively. Other severe non-hematologic toxicities were rare. Conclusion: The interesting tumor growth control rate and the favorable toxicity profile of the GEMOX regimen in pretreated patients with advanced CRC strongly suggest that this regimen may provide an alternative therapeutic option for this group of patients.

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Section: Discussionmentioning

confidence: 99%

“…Gemcitabine monotherapy has been registered as standard treatment of pancreatic cancer and proved active in other malignancies including lung, urothelial, breast and ovarian cancer. In advanced CRC, however, gemcitabine alone has minimal activity [17, 18]. …”

Section: Introductionmentioning

confidence: 99%

Multicenter Phase II Study of Gemcitabine and Oxaliplatin (GEMOX) as Second-Line Chemotherapy in Colorectal Cancer Patients Pretreated with 5-Fluorouracil plus Irinotecan

Ziras

Potamianou²,

Varthalitis³

et al. 2006

Oncology

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“…head and neck cancer (Braakhuis et al, 1991), colorectal cancer (Moore et al, 1992) and non-small cell lung cancer (Lilenbaum et al, 1993). However, no large clinical trial…”

Section: Introductionmentioning

confidence: 99%

Gemcitabine in Treating Patients with Refractory or Relapsed Multiple Myeloma

Zheng

Yang²

2014

Asian Pacific Journal of Cancer Prevention

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Background: Patients with refractory or relapsed multiple myeloma are considered to have a very poor prognosis, and new regimens are needed to improve the outcome. Gemcitabine, a nucleoside antimetabolite, is an analog of deoxycytidine which mainly inhibits DNA synthesis through interfering with DNA chain elongation and depleting deoxynucleotide stores, resulting in gemcitabine-induced cell death. Here we performed a systemic analysis to evaluate gemcitabine based chemotherapy as salvage treatment for patients with refractory and relapsed multiple myeloma. Methods: Clinical studies evaluating the impact of gemcitabine based regimens on response and safety for patients with refractory and relapsed multiple myeloma were identified by using a predefined search strategy. Pooled response rate (RR) of treatment were calculated. Results: In gemcitabine based regimens, 3 clinical studies which including 57 patients with refractory and relapsed multiple myeloma were considered eligible for inclusion. Systemic analysis suggested that, in all patients, pooled RR was 15.7% (9/57) in gemcitabine based regimens. Major adverse effects were hematologic toxicity, including grade 3 or 4 anemia, leucopenia and thrombocytopenia i. No treatment related death occurred with gemcitabine based treatment. Conclusion: This systemic analysis suggests that gemcitabine based regimens are associated with mild activity with good tolerability in treating patients with refractory or relapsed multiple myeloma.

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“…It has also shown preclinical and clinical activity in several other solid tumours, including ovarian, head and neck and breast cancers (Carmichael et al, 1995;Markman, 2002). However, phase I/II trials of single-agent gemcitabine have not demonstrated any activity in advanced colorectal and gastric cancers (Moore et al, 1992;Christman et al, 1994;Mani et al, 1998). We therefore wished to test this combination on further gastrointestinal tumour samples and investigate any schedule dependency.…”

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confidence: 99%

Combination chemotherapy in advanced gastrointestinal cancers: ex vivo sensitivity to gemcitabine and mitomycin C

et al. 2003

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Advanced or metastatic disease is common in both oesophagogastric and colorectal cancers, with poor 5-year survival despite palliative chemotherapy. We have investigated the sensitivity of gastrointestinal tumours to gemcitabine in combination with mitomycin C (GeM), using a modified ex vivo ATP-based tumour chemosensitivity assay (ATP-TCA). Tumour material from 41 colorectal and 22 oesophagogastric cancers were assessed. The GeM combination showed variable but definite activity in most of the samples tested. The results show that GeM achieves 495% inhibition at concentrations within the range achievable clinically in 60% of colorectal tumours (21 out of 35) and 38% of oesophagogastric tumours (five out of 13) tested. We did not identify any significant difference in sensitivity using concurrent or sequential exposure of tumour-derived cells to these two drugs. The results from this study suggest that GeM may be a useful combination in the treatment of advanced gastrointestinal malignancy.

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Phase II study of gemcitabine in advanced colorectal adenocarcinoma

Cited by 32 publications

References 14 publications

Multicenter Phase II Study of Gemcitabine and Oxaliplatin (GEMOX) as Second-Line Chemotherapy in Colorectal Cancer Patients Pretreated with 5-Fluorouracil plus Irinotecan

Multicenter Phase II Study of Gemcitabine and Oxaliplatin (GEMOX) as Second-Line Chemotherapy in Colorectal Cancer Patients Pretreated with 5-Fluorouracil plus Irinotecan

Gemcitabine in Treating Patients with Refractory or Relapsed Multiple Myeloma

Combination chemotherapy in advanced gastrointestinal cancers: ex vivo sensitivity to gemcitabine and mitomycin C

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