Ifosfamide plus paclitaxel in advanced non-small-cell lung cancer: A phase I study

Masters, Gregory A.; Drinkard, L. C.; Krauss, Stephen; Samuels, Brian L.; Golomb, Harvey M.; Vokes, Everett E.

doi:10.1093/oxfordjournals.annonc.a010578

Cited by 15 publications

(8 citation statements)

References 4 publications

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“…This paclitaxel MTD in children was higher than in adult combination studies employing different paclitaxel infusion durations. In adults, when paclitaxel was administered over either 24 hours or 3 hours on day 1 in combination with ifosfamide on days 1–3, the paclitaxel MTD was 250 mg/m 2 (14,15). Lower dose paclitaxel (135 mg/m 2 ) was chosen for combination study with ifosfamide in the Gynecologic Oncology Group Phase III trial in patients with advanced uterine carcinosarcoma (20).…”

Section: Discussionmentioning

confidence: 99%

“…Neutropenia was not considered dose-limiting in three of six adult Phase I trials employing paclitaxel in combination with ifosfamide due to the definition of DLT rather than the absence of significant myelosuppression (15,17,22–24,28). In the current study, myelosuppression, thrombocytopenia, and anemia were common; however, the frequency of bone marrow suppression was similar to that seen in 33 chemotherapy-naive pediatric neuroblastoma patients treated with single agent paclitaxel via a 24-hour infusion at the MTD of 350 mg/m 2 (26).…”

Section: Discussionmentioning

confidence: 99%

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Phase I study of paclitaxel with standard dose ifosfamide in children with refractory solid tumors: A Pediatric Oncology Group study (POG 9376)

Geller

Wall

Perentesis

et al. 2009

Pediatric Blood & Cancer

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PURPOSE A dose-escalation Phase I study of taxol (paclitaxel) administered in combination with standard dose ifosfamide was conducted in children with relapsed or refractory solid tumors. Primary objectives were to estimate the maximum-tolerated dose (MTD) and to describe the dose-limiting toxicities (DLTs). PATIENTS AND METHODS Paclitaxel was administered as a 6-hour continuous infusion (hr 0–6), followed by intravenous ifosfamide (2 gm/m2 /day × 3days) over 1 hr at hours 6–7, 24–25, and 48–49. Patients at dose level 1 received 250 mg/m2 paclitaxel. Subsequent dose escalation proceeded using a standard 3×3 Phase I design. RESULTS Fifteen patients received a combined 46 courses of therapy. The median age was 14.5 years (range, 2 to 19 years), and diagnoses included sarcoma (7), neuroblastoma (3), and other (5). Three patients received paclitaxel at 250 mg/m2 (10 courses), six at 325 mg/m2 (19 courses), three at 425 mg/m2 (8 courses), and three at 550 mg/m2 (9 courses). DLTs occurred in 2/3 patients at 550 mg/m2 paclitaxel during cycle 1, including grade 3 hypotension and grade 4 anaphylaxis in 1 patient each. Common non-dose limiting toxicities included bone marrow suppression and peripheral neuropathy. Response was evaluable in 14 patients and included mixed response (3), stable disease (5) and progressive disease (6). CONCLUSION Paclitaxel hypersensitivity reactions were dose limiting when the drug was administered as a 6-hour infusion. The MTD and recommended Phase II dose of paclitaxel administered as a six-hour continuous intravenous infusion followed by standard dose intravenous ifosfamide is 425 mg/m2 paclitaxel.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Phase I study of paclitaxel with standard dose ifosfamide in children with refractory solid tumors: A Pediatric Oncology Group study (POG 9376)

Geller

Wall

Perentesis

et al. 2009

Pediatric Blood & Cancer

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“…Compared with cisplatin-based chemotherapy, these trials also reported a milder toxicity profile, particularly nausea/vomiting. Taxanes plus gemcitabine regimens and ifosfamide plus a new agent chemotherapy were reported to have similar levels of efficacy and tolerability [39, 40, 41, 42, 43, 44, 45]. Because the major toxicity of ifosfamide is myelosuppression, the nonhematologic toxicity profiles of ifosfamide combined with other agents are only minimally overlapped.…”

Section: Discussionmentioning

confidence: 99%

Phase II Study of Irinotecan and Ifosfamide in Patients with Advanced Non-Small Cell Lung Cancer

Ichiki

Rikimaru²,

Gohara³

et al. 2003

Oncology

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Objectives: This phase II study was conducted to investigate the efficacy and safety of irinotecan (CPT-11) and ifosfamide as first-line chemotherapy for advanced non-small cell lung cancer (NSCLC). Methods: Eligibility criteria included histologically or cytologically confirmed NSCLC (stage IIIb or IV), no prior treatment, and measurable or evaluable disease. CPT-11 (80 mg/m²) was administered intravenously on days 1, 8, and 15, while ifosfamide (1.5 g/m²) was given on days 1 through 3 every 4 weeks. Results: Forty-four patients (31 men) with a median age of 65 years (range 43–75) and a median ECOG performance status of 1 (range 0–2) were enrolled. The response rate was 29.5% [95% CI: 16.7–45.2%], with 13 partial responses. The median survival was 12.5 months, the median time to progression was 5.3 months, and the 1 and 2-year survival rates were 52.3 and 11.3%, respectively. Toxicity was generally mild; WHO grade 3–4 neutropenia was recorded in 38.6% of the patients, grade 3 diarrhea in 6.8%, and grade 3–4 nausea/vomiting in 0%. Conclusions: CPT-11 combined with ifosfamide demonstrated anti-tumor activity in advanced NSCLC, with response and survival rates similar to those of cisplatin-based chemotherapy but with a more favorable toxicity profile.

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“…G-CSF was administered on days 4–10. Partial responses were observed in 7 patients (23%), all in the group of 18 that received taxol at dose levels of ≥250 mg/m 2 [25]. On the bases of this study, the CALGB group conducted a phase II study with taxol 250 mg/m 2 in a 1-hour infusion.…”

Section: New Drug Combinationsmentioning

confidence: 99%

Ifosfamide in Non-Small Cell Lung Cancer

Boni¹,

Zanelli²

2003

Oncology

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In recent years the role of chemotherapy in advanced non-small cell lung cancer (NSCLC) has been well established. Ifosfamide is an old drug still considered an effective cytostatic agent in the treatment of NSCLC. As a single agent, it has showed a response rate of 20–25%. These results are improved when it is used in combination with cisplatin and mitomycin C. Moreover, in recent years, several new drugs like gemcitabine, taxanes and vinorelbine have been identified, and combinations of two or three drugs have been tested in patients with advanced NSCLC. This paper reviews the main studies recently conducted for the treatment of NSCLC, considering the results obtained by ifosfamide alone and in combination. Three-drug regimens including first-generation cytostatic agents achieve a response rate of about 40% and median survival of 10 months. In combinations with new drugs, ifosfamide shows an improvement in response rate (50%) with a median survival of more than 1 year. Open questions in the treatment of NSCLC are whether three-drug are better than two-drug combinations, and whether cisplatin is still required.

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Ifosfamide plus paclitaxel in advanced non-small-cell lung cancer: A phase I study

Cited by 15 publications

References 4 publications

Phase I study of paclitaxel with standard dose ifosfamide in children with refractory solid tumors: A Pediatric Oncology Group study (POG 9376)

Phase I study of paclitaxel with standard dose ifosfamide in children with refractory solid tumors: A Pediatric Oncology Group study (POG 9376)

Phase II Study of Irinotecan and Ifosfamide in Patients with Advanced Non-Small Cell Lung Cancer

Ifosfamide in Non-Small Cell Lung Cancer

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