WARNINGS
- Severe local tissue necrosis will occur if there is extravasation during administration (see DOSAGE AND ADMINISTRATION). Doxorubicin must not be given by the intramuscular or subcutaneous route.
- Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The probability of developing impaired myocardial function based on a combined index of signs, symptoms and decline in left ventricular ejection fraction (LVEF) is estimated to be 1 to 2% at a total cumulative dose of 300 mg/m2 of doxorubicin, 3 to 5% at a dose of 400 mg/m2, 5 to 8% at 450 mg/m2 and 6 to 20% at 500 mg/m2*. The risk of developing CHF increases rapidly with increasing total cumulative doses of doxorubicin in excess of 450 mg/m2. This toxicity may occur at lower cumulative doses in patients with prior mediastinal irradiation or on concurrent cyclophosphamide therapy or with pre-existing heart disease. Pediatric patients are at increased risk for developing delayed cardiotoxicity.
- Dosage should be reduced in patients with impaired hepatic function.
- Severe myelosuppression may occur.
- Doxorubicin should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
* Data on file at Pharmacia & Upjohn.
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RUBEX SUMMARY
RUBEX®
(doxorubicin hydrochloride for injection, USP)
Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var. caesius. Doxorubicin consists of a naphthacenequinone nucleus linked through a glycosidic bond at ring atom 7 to an amino sugar, daunosamine.
RUBEX (doxorubicin) is indicated for the following:
RUBEX (doxorubicin hydrochloride for injection, USP) has been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types.
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NEWS HIGHLIGHTSMedia Articles Related to Rubex (Doxorubicin)
CytRx To Initiate Phase 2 Clinical Trial With INNO-206 In Patients With Advanced Gastric Cancer
Source: Health News from Medical News Today [2009.11.19]
CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical company, today announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer. CytRx President and CEO Steven A.
Published Studies Related to Rubex (Doxorubicin)
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.
A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinoma. [2009.09]
Hepatocellular carcinoma (HCC) is a major and often therapeutically frustrating oncological problem. A total of 100 patients with unresectable HCC were recruited and randomized to be treated with either transcatheter arterial chemoembolization (TACE) or systemic chemotherapy... In this setting, serum albumin level is a candidate marker for selection of cases who may benefit from this procedure.
Phase III trial of doxorubicin plus cyclophosphamide (AC), docetaxel, and alternating AC and docetaxel as front-line chemotherapy for metastatic breast cancer: Japan Clinical Oncology Group trial (JCOG9802). [2009.07]
BACKGROUND: This randomized, multicenter, phase III trial compared doxorubicin plus cyclophosphamide (AC), single-agent docetaxel (D), and an alternating regimen of AC and docetaxel (AC-D) as first-line chemotherapy in metastatic breast cancer (MBC)... CONCLUSION: There was no difference in the TTF among the three arms. However, there was a trend toward a better response and better OS in the D than in the AC.
Appraising cardiotoxicity associated with liposomal doxorubicin by means of tissue Doppler echocardiography end-points: rationale and design of the LITE (Liposomal doxorubicin-Investigational chemotherapy-Tissue Doppler imaging Evaluation) randomized pilot study. [2009.06.12]
BACKGROUND: Cardiomyopathy following anthracycline chemotherapy may have ominous clinical implications in cancer patients treated with this effective yet potentially toxic therapy. Early detection at subclinical stage is pivotal to minimize the risk of overt cardiotoxicity. Liposomal anthracyclines have the potential for more selective uptake by cancer cells and reduced cardiac toxicity. OBJECTIVE: We designed a single-center randomized clinical trial, the Liposomal doxorubicin-Investigational chemotherapy-Tissue Doppler imaging Evaluation (LITE) pilot study to compare the safety of liposomal doxorubicin vs standard epirubicin in terms of clinical and subclinical cardiotoxicity... CONCLUSIONS: Results of the LITE pilot study should provide important clinical and mechanistic insights on the promising role of liposomal anthracyclines in patients with breast cancer and indication to anthracycline chemotherapy (ClinicalTrials.gov identifier NCT00531973).
Phase III trial evaluating the addition of paclitaxel to doxorubicin followed by cyclophosphamide, methotrexate, and fluorouracil, as adjuvant or primary systemic therapy: European Cooperative Trial in Operable Breast Cancer. [2009.05.20]
PURPOSE: To evaluate the addition of paclitaxel to an anthracycline-based adjuvant regimen and to compare this combination with the same regimen given as primary systemic (neoadjuvant) therapy... CONCLUSION: Incorporating paclitaxel into anthracycline-based adjuvant therapy resulted in a significant improvement in RFS and distant RFS. When given as primary systemic therapy, the paclitaxel-containing regimen allowed breast-sparing surgery in a significant percentage of patients.
Clinical Trials Related to Rubex (Doxorubicin)
Vincristine, DOXIL® (Doxorubicin HCl Liposome Injection) and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma [Completed]
The purpose of this study is to determine how well newly diagnosed multiple myeloma patients
respond to an experimental regimen of Vincristine, DOXIL (doxorubicin HCl liposome injection)
and Dexamethasone (VDD) versus the standard treatment of Vincristine, Doxorubicin and
Dexamethasone (VAD).
A Comparison of DOX-SL Versus Adriamycin Plus Bleomycin Plus Vincristine in the Treatment of Severe AIDS-Related Kaposi's Sarcoma [Active, not recruiting]
To determine the efficacy of Stealth liposomal doxorubicin hydrochloride (DOX-SL) in the
treatment of severe AIDS-related Kaposi's sarcoma (KS) by comparison with the established
therapy ABV: Adriamycin (doxorubicin)/bleomycin/vincristine. To evaluate the safety and
tolerance of DOX-SL compared to ABV in a population of AIDS patients with severe KS.
A Study Comparing the Combination of Doxil and Yondelis, to Doxil Alone for Subjects With Ovarian Cancer [Active, not recruiting]
The purpose of this research study is to determine if the combination of Yondelis and Doxil
is better at improving overall survival over Doxil alone in subjects with relapsed advanced
ovarian cancer.
A Study of Docetaxel Monotherapy or DOXIL®/CAELYX® and Docetaxel in Patients With Advanced Breast Cancer [Active, not recruiting]
This study will evaluate the safety and effectiveness of a combination of doxorubicin HCl
liposome injection (DOXIL/CAELYX) and docetaxel in women with recurrent advanced breast
cancer who received anthracycline in the adjuvant or neoadjuvant setting.
The safety and effectiveness of the combination will be compared to treatment with docetaxel
alone (monotherapy). The purpose of this research study is to determine if overall survival
for the docetaxel and DOXIL/CAELYX treated group is longer than that for the group treated
with docetaxel alone. Additional comparisons between the two treatment groups include:
response rate (how much your tumor shrinks in response to the drug), time to progression,
safety, and quality of life.
Thalidomide + Dexamethasone vs. DOXIL (Doxorubicin HCl Liposome Injection) + Thalidomide + Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma [Active, not recruiting]
The main purpose of this study is to determine if Thalidomide + Dexamethasone or DOXIL
(doxorubicin HCl liposome injection) + Thalidomide + Dexamethasone is more effective in
treating patients newly diagnosed with multiple myeloma. The number of patients whose
multiple myeloma disappears for a period of time (also called "Complete Response") will be
studied to make the determination of which treatment is more effective.
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Page last updated: 2009-11-19
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