Hycamtin (Topotecan Hydrochloride) - Summary

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).

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NEWS HIGHLIGHTS

Media Articles Related to Hycamtin (Topotecan)

Thalidomide plus Topotecan better for ovarian cancer
Source: The Doctors Lounge - Oncology
This trial is among the first to combine a biologic agent with a conventional chemotherapy agent for ovarian cancer.

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Published Studies Related to Hycamtin (Topotecan)

Effects of concurrent topotecan and radiation on 6-month progression-free survival in the primary treatment of glioblastoma multiforme. [2009.09.01]
PURPOSE: To report a prospective, randomized, Phase II trial of radiotherapy with and without topotecan for the treatment of glioblastoma... CONCLUSIONS: A slight but measurable increase of 16% was detected in 6-m-PFS for patients receiving topotecan with radiation as compared with patients having radiotherapy alone. These data might support further investigations into topotecan for the treatment of glioblastoma.

Phase 3 randomised study of canfosfamide (Telcyta, TLK286) versus pegylated liposomal doxorubicin or topotecan as third-line therapy in patients with platinum-refractory or -resistant ovarian cancer. [2009.09]
RATIONALE: Canfosfamide HCl (CAN) is a glutathione analogue prodrug that is activated by glutathione S-transferase P1-1 and induces apoptosis. CAN is synergistic in vitro with carboplatin, paclitaxel and anthracyclines... CONCLUSION: CAN was well tolerated. This is the first randomised study showing an increased OS with third-line therapy. This might have important consequences for other recurrent OC trials.

Topotecan versus treosulfan, an alkylating agent, in patients with epithelial ovarian cancer and relapse within 12 months following 1st-line platinum/paclitaxel chemotherapy. A prospectively randomized phase III trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group (AGO-OVAR). [2009.08]
OBJECTIVE: Effective therapies with a low rate of side effects are warranted in the 2nd-line setting in ovarian cancer. Both topotecan and the alkylating agent treosulfan have demonstrated efficacy in this patient group and are broadly used in Germany. Therefore, we started a prospectively randomized phase III trial comparing these two drugs in early recurrent ovarian cancer... CONCLUSIONS: This randomized phase III trial could detect superiority of topotecan versus treosulfan in patients with recurrent disease after platinum-paclitaxel combination therapy. Our experience indicates that optimization of systemic treatment could improve outcome even in this poor prognostic subgroup of patients with relapsed ovarian cancer.

Bioequivalence study of a new oral topotecan formulation, relative to the current topotecan formulation, in patients with advanced solid tumors. [2009.03]
OBJECTIVE: The aims of this study were to investigate the bioequivalence of a new oral topotecan formulation (i.e., proposed commercial formulation) relative to the current oral formulation (formulation used in previous clinical trials), the effect of food on the absorption and disposition of the new oral topotecan and its safety and tolerability in patients with advanced solid tumors... CONCLUSION: The new oral topotecan formulation demonstrated bioequivalence to the current formulation and demonstrated it can be administered to patients with solid tumors in the fed or fasted state with similar systemic exposure.

Randomized phase II trial comparing amrubicin with topotecan in patients with previously treated small-cell lung cancer: North Japan Lung Cancer Study Group Trial 0402. [2008.11.20]
PURPOSE: Amrubicin, a new anthracycline agent, and topotecan are both active for previously treated small-cell lung cancer (SCLC). No comparative study of these agents has been reported. This randomized phase II study was conducted to select amrubicin or topotecan for future evaluation... CONCLUSION: Amrubicin may be superior to topotecan with acceptable toxicity for previously treated patients with SCLC. Further evaluation of amrubicin for relapsed SCLC is warranted.

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Clinical Trials Related to Hycamtin (Topotecan)

Topotecan Vs. Topotecan + Etoposide Vs.Topotecan + Gemcitabine in Ovarian Cancer Therapy [Completed]
Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.

A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor [Completed]
St. Jude Children's Research Hospital is studying ways to improve the outcome of patients with recurrent Wilms tumor, a form of kidney cancer. Wilms tumor is the fourth most common cancer of childhood, accounting for 7 percent of pediatric cancers. Despite the overall success of Wilms tumor treatment, children who have recurrent Wilms tumor (cancer that comes back after it was previously treated) have a poor prognosis. A drug called topotecan has shown promising results in previous research studies to treat children with other types of cancer. Researchers want to learn if topotecan will have an effect on recurrent Wilms tumor. Because it is not known if the drug will work, this is a research study.

A Bioequivalence Study of Two Oral Formulations of Topotecan in Patients With Advanced Solid Tumors [Completed]
The purpose of this study is to compare two capsules of topotecan made by slightly different methods. This will be done by giving the drug made by the two different methods to patients orally and testing blood levels.

Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-Resistant Ovarian Cancer [Active, not recruiting]
Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.

Efficacy Study of Weekly Topotecan With Cisplatin in Advanced Stage or Recurrent Cervical Cancer [Terminated]
The purpose of this study is to determine the maximum tolerated dose (MTD) of topotecan when given weekly with cisplatin in patients with persistent, recurrent, or advanced stage cervical cancer. Secondary purposes are to describe the toxicity profile in patients with persistent, recurrent, or advanced stage cervical cancer treated with the combination of topotecan when given weekly with cisplatin and to determine the response rate and time to progression in patients with persistent, recurrent, or advanced stage cervical cancer treated with the combination of topotecan when given weekly with cisplatin.

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