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Hycamtin (Topotecan Hydrochloride) - Summary

 

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WARNING

HYCAMTIN (topotecan hydrochloride) for Injection should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.

Therapy with HYCAMTIN should not be given to patients with baseline neutrophil counts of less than 1,500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection and death, frequent peripheral blood cell counts should be performed on all patients receiving HYCAMTIN.

 

HYCAMTIN SUMMARY

HYCAMTIN (topotecan hydrochloride) is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.

HYCAMTIN is indicated for the treatment of:

  • metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy.
  • small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the Phase 3 study) or at least 90 days (in the Phase 2 studies) after chemotherapy (see CLINICAL STUDIES).

HYCAMTIN NEWS HIGHLIGHTS

Media Articles Related to Hycamtin (Topotecan)

Thalidomide plus Topotecan better for ovarian cancer
Source: The Doctors Lounge - Oncology

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Published Studies Related to Hycamtin (Topotecan)

A prospective randomized trial of thalidomide with topotecan compared with topotecan alone in women with recurrent epithelial ovarian carcinoma. [2008.01.15]

A prospective phase II study of induction carboplatin and vinorelbine followed by concomitant topotecan and accelerated radiotherapy (ART) in locally advanced non-small cell lung cancer (NSCLC). [2007.09]

Phase II trial of paclitaxel-topotecan-etoposide followed by consolidation chemoradiotherapy for limited-stage small cell lung cancer: CALGB 30002. [2007.07]

Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. [2007.05.20]

Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. [2006.12.01]

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Clinical Trials Related to Hycamtin (Topotecan)

Phase 1 Topotecan for Neoplastic Meningitis [Suspended]

Topotecan Vs. Topotecan + Etoposide Vs.Topotecan + Gemcitabine in Ovarian Cancer Therapy [Completed]

A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor [Completed]

A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors [Completed]

Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-Resistant Ovarian Cancer [Active, not recruiting]

more>>

Page last updated: 2008-03-26

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