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Hycamtin (Topotecan Hydrochloride) - Summary



Do not give HYCAMTIN® to patients with baseline neutrophil counts 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, monitor peripheral blood counts frequently on all patients receiving HYCAMTIN [see Warnings and Precautions].



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(14)].

HYCAMTIN in combination with cisplatin is indicated for the treatment of:

  • •Stage IV-B, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.

See all Hycamtin indications & dosage >>


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.

more news >>

Published Studies Related to Hycamtin (Topotecan)

A phase II study of two topotecan regimens evaluated in recurrent platinum-sensitive ovarian, fallopian tube or primary peritoneal cancer: a Gynecologic Oncology Group Study (GOG 146Q). [2011.03]
OBJECTIVE: To evaluate the efficacy and safety of topotecan in patients with recurrent ovarian, primary peritoneal, and fallopian tube carcinomas... CONCLUSION: The weekly regimen of topotecan appeared less active but resulted in less toxicity than the daily regimen in platinum-sensitive recurrent ovarian cancer patients. Copyright (c) 2010. Published by Elsevier Inc.

Randomized phase II trial of single-agent amrubicin or topotecan as second-line treatment in patients with small-cell lung cancer sensitive to first-line platinum-based chemotherapy. [2011.01.20]
PURPOSE: This phase II study evaluated the safety and efficacy of single-agent amrubicin versus topotecan in patients with small-cell lung cancer (SCLC) sensitive to first-line platinum-based chemotherapy... CONCLUSION: Amrubicin shows promising activity, with an ORR of 44% compared with an ORR of 15% for topotecan as second-line treatment in patients with SCLC sensitive to first-line platinum-based chemotherapy. In addition, the safety profiles were comparable; however, a trend was noted for more frequent grade 3 or worse neutropenia and thrombocytopenia in the topotecan group as compared with the amrubicin group. Additional studies are ongoing.

Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer: a randomized multicenter phase II trial of the North-Eastern German Society of Gynecological Oncology Ovarian Cancer Study Group. [2011.01.10]
PURPOSE: Weekly administration of topotecan (Tw) is less toxic and widely considered a better treatment option than conventional 5-day therapy (Tc) in women with platinum-resistant recurrent ovarian cancer. We conducted a randomized phase II trial (TOWER [Topotecan Weekly Versus Conventional 5-Day Schedule in Patients With Platinum-Resistant Ovarian Cancer]) to better define the ratio between benefits and risks with either treatment approach... CONCLUSION: With regard to effectiveness in terms of response and PFS, Tc remains the standard of care in patients with platinum-resistant recurrent ovarian cancer. However, comparable OS rates and a favorable toxicity profile make Tw another viable treatment option in this setting.

Paclitaxel/carboplatin versus topotecan/paclitaxel/carboplatin in patients with FIGO suboptimally resected stage III-IV epithelial ovarian cancer a multicenter, randomized study. [2010.11]
OBJECTIVE: The objective of this prospective randomized phase III trial was to compare paclitaxel plus carboplatin (PC) versus topotecan plus carboplatin and paclitaxel (TPC) in women with suboptimal stage III (residual tumour >1cm) or stage IV ovarian cancer to evaluate the survival rate and toxicities... CONCLUSION: The results of the present study show that the addition of topotecan to a standard paclitaxel/carboplatin regimen in the treatment of advanced epithelial ovarian cancer did not result in significant advantages in terms of survival rate. A slightly worse toxicity profile for TPC was observed. Copyright (c) 2010. Published by Elsevier Ltd.

Advanced ovarian cancer: phase III randomized study of sequential cisplatin-topotecan and carboplatin-paclitaxel vs carboplatin-paclitaxel. [2010.10.20]
BACKGROUND: Topotecan has single-agent activity in recurrent ovarian cancer. It was evaluated in a novel combination compared with standard frontline therapy... CONCLUSIONS: Topotecan and cisplatin, followed by carboplatin and paclitaxel, were more toxic than carboplatin and paclitaxel alone, but without improved efficacy. Carboplatin plus paclitaxel remains the standard of care for advanced epithelial ovarian cancer.

more studies >>

Clinical Trials Related to Hycamtin (Topotecan)

Phase 1 Intrathecal Topotecan for Neoplastic Meningitis [Recruiting]
1. To find the optimal dose of topotecan that can safely be given directly into the spinal fluid (called intrathecal administration) of children whose cancer has spread to the lining of the brain and/or spinal cord.

2. To find out what effects (good and bad) topotecan has when given directly into the cerebrospinal fluid in children with neoplastic meningitis (cancer that has spread to the lining of the brain and spinal cord).

- Cerebrospinal fluid is the fluid that circulates around the brain and spinal cord.

3. To determine if intrathecal topotecan is beneficial to patients.

4. To better understand how topotecan is handled by the body after intrathecal administration.

5. To evaluate the cerebrospinal fluid for signs (markers) of tumor spread.

Study of Temsirolimus, Topotecan, and Bortezomib [Recruiting]
The goal of this clinical research study is to find the highest tolerable dose of Torisel (temsirolimus), Hycamtin (topotecan hydrochloride), and Velcade (bortezomib) that can be given, in combination, to patients with advanced cancer that has spread or is unable to be surgically removed. The safety of this drug combination will also be studied.

A Phase 1b Study of AMG 386 in Combination With Either Pegylated Liposomal Doxorubicin or Topotecan in Subjects With Advanced Recurrent Epithelial Ovarian Cancer [Recruiting]
This study is a 2 part, 2 cohort, open-label, dose escalation/de escalation study of AMG 386 in combination with either pegylated liposomal doxorubicin or topotecan in subjects with recurrent ovarian cancer. Up to 100 subjects will be enrolled to receive AMG 386 in combination with either pegylated liposomal doxorubicin every 4 weeks (cohort A) or topotecan weekly on days 1, 8, and 15 of a 28 day dosing schedule (cohort B). Subject enrollment and assignment to either cohort will be based on eligibility and the investigator's discretion.

It is hypothesized that AMG 386, in combination with each of the chemotherapy regimens: either pegylated liposomal doxorubicin or topotecan will be safe and well tolerated in subjects with recurrent ovarian cancer.

Topotecan With Erlotinib for Topotecan Pretreated Ovarian Cancer [Recruiting]
This is a single arm phase II study with a combination of Hycamptin (topotecan) and erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent ovarian cancer previously treated with chemotherapy drug Hycamptin (topotecan). Up to 30 patients will be enrolled in this study.

Trial of High Dose Topotecan With Carboplatin in Patients With Relapsed Ovarian Carcinoma [Recruiting]
The early relapse of ovarian cancer occurring within 6 months of chemotherapy including platinum regimen are called relapses 'platinum resistant' consecutively patients die quickly of their disease. For relapses occurring between 6 and 12 months, no recommendation occur and few studies are conducted. Therefore it seems interesting to develop a research on intensive chemotherapy using a combination of carboplatin (a drug widely used in most ovarian cancer) with Topotecan , use in a high dose protocol. Topotecan has demonstrated its efficacy in relapse ovarian cancer and its possible use in high doses, a recent study (ITOV01) have demonstrated the feasibility of dose escalation of topotecan monotherapy (MTD set at 9 mg / m² / dx 5 days). This project is a feasibility research of the combination of topotecan and carboplatin in a high dose escalation protocol for early ovarian cancer relapse occurring 6 to 12 months after conventional chemotherapy-based platinum salts.

more trials >>

Reports of Suspected Hycamtin (Topotecan) Side Effects

White Blood Cell Count Decreased (37)Neutrophil Count Decreased (34)Platelet Count Decreased (32)Anaemia (28)Death (24)RED Blood Cell Count Decreased (21)Nausea (13)Decreased Appetite (11)Febrile Neutropenia (11)Fatigue (10)more >>

Page last updated: 2011-12-09

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