Vepesid (Etoposide) - Summary

VEPESID SUMMARY

VePesid^®
(etoposide)
Capsules

VePesid^® (etoposide) (also commonly known as VP-16) is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. It is 4'-demethylepipodophyllotoxin 9-[4,6-O-(R)-ethylidene-β-D-glucopyranoside]. It is very soluble in methanol and chloroform, slightly soluble in ethanol, and sparingly soluble in water and ether. It is made more miscible with water by means of organic solvents.

VePesid (etoposide) is indicated in the management of the following neoplasms:

Refractory Testicular Tumors— VePesid For Injection in combination therapy with other approved chemotherapeutic agents in patients with refractory testicular tumors who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy.

Adequate data on the use of VePesid Capsules in the treatment of testicular cancer are not available.

Small Cell Lung Cancer— VePesid For Injection and/or Capsules in combination with other approved chemotherapeutic agents as first line treatment in patients with small cell lung cancer.

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NEWS HIGHLIGHTS

Published Studies Related to Vepesid (Etoposide)

Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124. [2009.05.20]
PURPOSE: Irinotecan plus cisplatin (IP) improved survival over etoposide plus cisplatin (EP) in Japanese patients with extensive-stage small-cell lung cancer (E-SCLC). To confirm those results and discern the potential role of population-related pharmacogenomics (PG) in outcomes, we conducted a large randomized trial of identical design to the Japanese trial in North American patients with E-SCLC... CONCLUSION: This large North American trial failed to confirm the previously reported survival benefit observed with IP in Japanese patients. Both regimens produced comparable efficacy, with less hematologic and greater gastrointestinal toxicity with IP. These results emphasize the potential importance of PG in interpreting trials of cancer therapy.

PROCLAIM: A phase III study of pemetrexed, cisplatin, and radiation therapy followed by consolidation pemetrexed versus etoposide, cisplatin, and radiation therapy followed by consolidation cytotoxic chemotherapy of choice in locally advanced stage III non-small-cell lung cancer of other than predominantly squamous cell histology. [2009.05]
This clinical trial summary provides the background and rationale for a randomized trial examining the benefits of pemetrexed/ cisplatin chemotherapy combined with radiation followed by consolidation pemetrexed in patients with unresectable stage IIIA/B non-small-cell lung cancer.

Chemotherapy: The role of ifosfamide and etoposide in Ewing sarcoma. [2009.05]
The EICESS-92 Trial compared the efficacy of cyclophosphamide and ifosfamide in patients with Ewing sarcoma. Subgroup analysis suggested that patients with large, localized tumors benefited from the addition of etoposide, whereas patients with metastases did not..

Phase III multi-institutional trial of adjuvant chemotherapy with paclitaxel, estramustine, and oral etoposide combined with long-term androgen suppression therapy and radiotherapy versus long-term androgen suppression plus radiotherapy alone for high-risk prostate cancer: preliminary toxicity analysis of RTOG 99-02. [2009.03.01]
CONCLUSION: TEE was associated with significantly increased toxicity during treatment. The toxicity profiles did not differ at 2 and 3 years after therapy. Toxicity is an important consideration in the design of trials using adjuvant chemotherapy for prostate cancer.

EPO in combination with G-CSF improves mobilization effectiveness after chemotherapy with ifosfamide, epirubicin and etoposide and reduces costs during mobilization and transplantation of autologous hematopoietic progenitor cells. [2009.02]
A successful stem cell harvest is a prerequisite for peripheral blood SCT. We investigated the number of CD34(+) cells mobilized, the number of leukaphereses needed and the expenses of treatment for 28 patients with multiple myeloma randomly assigned to receive either G-CSF alone or G-CSF+EPO for stem cell mobilization after chemotherapy with ifosfamide, epirubicin and etoposide...

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Clinical Trials Related to Vepesid (Etoposide)

Ph II Bev + Either Temo/Etoposide for GBM Pts Who Have Failed Bev + Irinotecan [Active, not recruiting]
Primary objective To estimate 6-month progression free survival probability of pts w recurrent GBM treated w bev + either daily temo/etoposide following progression on bev + irinotecan Secondary Objectives To evaluate safety & tolerability of bev + either daily temo/etoposide among pts w recurrent GBM who have progressed on bev + irinotecan To evaluate radiographic response, progression free survival & overall survival of pts w recurrent GBM treated w bev + either daily temo/etoposide following progression on bev + irinotecan

A Trial of Thalidomide, Celecoxib, Etoposide and Cyclophosphamide in Patients With Relapsed or Progressive Cancer [Completed]
This study will use a combination of four oral drugs (thalidomide, cyclophosphamide, etoposide and celecoxib) to treat patients with relapsed or progressive cancer. These drugs are expected to target the blood vessels that supply the tumors with what they need to grow.

Etoposide and G-CSF With or Without Rituximab in Treating Patients Who Are Undergoing an Autologous Peripheral Stem Cell Transplant For Non-Hodgkin's Lymphoma [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as busulfan, etoposide, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving colony-stimulating factors, such as G-CSF, monoclonal antibodies, such as rituximab, or chemotherapy, such as etoposide, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant. Giving etoposide and G-CSF together with rituximab before a peripheral stem cell transplant may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: This randomized clinical trial is studying how well giving etoposide and G-CSF with or without rituximab works in treating patients who are undergoing an autologous peripheral stem cell transplant for B-cell non-Hodgkin's lymphoma.

Cisplatin/Etoposide/Radiotherapy +/- Consolidation Docetaxel in Advanced Stage III Non-Small Cell Lung Cancer [Completed]
In a previous phase II study, patients with pathological stage IIIb (without pleural effusion) NSCLC were treated with concurrent cisplatin and etoposide plus thoracic radiotherapy followed by 3 cycles of consolidation therapy with docetaxel. Docetaxel was selected based upon a survival benefit in patients with recurrent NSCLC.

This trial will evaluate the role of consolidation therapy with docetaxel in patients with unresectable stage III disease. The purpose of the trial is to evaluate survival and toxicities of the regimens employed.

Ph I Dose Escalation Trial of Vandetanib in Combo w Etoposide for Malignant Gliomas [Recruiting]
Primary Objective To determine maximum tolerated dose & dose limiting toxicity of vandetanib when combo w standard dosing of etoposide among pts w recurrent malignant glioma who are on & not on enzyme-inducing anti-epileptic drugs Secondary Objectives To assess safety & tolerability of vandetanib + etoposide in population To evaluate pharmacokinetics of vandetanib among malignant glioma pts on & not on EIAEDs when combo w etoposide Exploratory Objective To evaluate for evidence of anti-tumor activity of study regimen among recurrent malignant glioma pts including radiographic response rate, 6-month progression free survival rate & median PFS

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