October 28th 2025
The FDA decision is based on data from a pooled analysis of phase 1/2 study data from 2 trials evaluating the agent in advanced/metastatic PROC.
Safety Data From North American Trials of Vinorelbine
October 2nd 1997Data from North American clinical trials have shown that vinorelbine (Navelbine) is well tolerated when used as a single agent for the treatment of non-small-cell lung cancer, advanced breast cancer, or ovarian cancer. Myelosuppression is the primary dose-limiting toxicity.
The Biodistribution and Pharmacokinetics of Stealth Liposomes in Patients with Solid Tumors
October 1st 1997Liposomes have been proposed as potential vehicles for drug therapy targeted to solid tumors, in particular, because of the increased permeability of these tumors to macromolecules. The recent development of Stealth
A Safety Review of Pegylated Liposomal Doxorubicin in the Treatment of Various Malignancies
October 1st 1997Many of the more commonly observed adverse effects of standard doxorubicin (Adriamycin) are lessened by pegylated liposomal delivery (Doxil). The slow release of doxorubicin into normal tissue cells via this form of liposomal delivery ameliorates its potential for severe alopecia, nausea and vomiting, cardiotoxicity, and myelosuppressive toxicity. Infusion-related acute reactions are managed by slowing infusion rates and thorough dilution and mixing of the infused drug. Vesicant properties normally seen with doxorubicin are absent. Palmar-plantar erythrodysesthesia can be reduced by decreasing the dose or increasing the dosing interval. Many of these side effects are developing a predictable profile and are manageable. Because of its overall reduced toxicity profile, pegylated liposomal doxorubicin may be well-suited for use in combination chemotherapeutic regimens. [ONCOLOGY 11(Suppl 11):54-62, 1997]
After pegylated liposomal doxorubicin (PEG-LD) (Doxil) was shown to be active in ovarian tumors, several trials were developed at the University of Southern California to determine its safety and efficacy in a variety of gynecologic and peritoneal malignancies. Completed phase I and phase II trials have found PEG-LD to be safe and effective in the treatment of platinum- and paclitaxel-refractory epithelial ovarian carcinoma. A new phase II trial is currently underway in similarly refractory patients with ovarian and other related cancers and various degrees of pretreatment. In addition, the efficacy of PEG-LD is being explored in combination with paclitaxel (Taxol), with cisplatin, and with hyperthermia. [ONCOLOGY 11(Suppl 11):38-44, 1997]
Rationale for Trials Studying Pegylated Liposomal Doxorubicin in Metastatic Breast Cancer
Breast cancer is second only to lung cancer as a leading cause of cancer mortality in women. In women with metastatic, hence, essentially incurable disease, we strive to find effective chemotherapeutic regimens that offer a
FDA Approves Taxol for Use in AIDS-Related KS
September 1st 1997ROCKVILLE, Md-The Food and Drug Administration (FDA) has cleared Bristol-Myers Squibb’s Taxol (paclitaxel) Injection for use in the second-line treatment of AIDS-related Kaposi’s sarcoma (KS). Taxol is also approved for second-line use in metastatic breast and ovarian cancer.
Ovarian Cancer Survivors Form National Coalition
August 1st 1997BOCA RATON, Fla--Ovarian cancer survivors have formed the National Ovarian Cancer Coalition (NOCC), an organization whose main mission is to prevent deaths from ovarian cancer by advocating for the development of new techniques for early detection and by raising awareness levels about the disease.
Women Who Seek BRCA1 Testing May Be More Distressed and Psychologically Vulnerable
August 1st 1997NEW ORLEANS--Women seeking BRCA1 testing appear, as a group, to be more distressed and psychologically vulnerable than those who do not wish to be tested, according to two studies from Lombardi Cancer Center, Georgetown University, reported at the American Society of Preventive Oncology annual meeting. The women in the studies were at high risk because of a close family history of breast or ovarian cancer.
Will Current Clinical Trials Answer the Most Important Questions About Prostate Adenocarcinoma?
August 1st 1997Despite a heightened focus of the medical and research community on prostate cancer, many important questions about this disease remain unanswered. These include questions about the possible prevention of prostate cancer, as well as the optimal treatment approaches for localized, locally advanced, metastatic, and hormone-refractory disease. A whole host of prospective, well-designed clinical trials are currently in progress that should answer many of these questions. This review briefly explores some of these unresolved issues and describes ongoing trials designed to address them. [ONCOLOGY 11(8):1-11, 1997]
Trial Attempts to Reverse Taxol Resistance in Ovarian Cancer
July 1st 1997ASCO--Use of the investigational resistance modulator PSC-833 in combination with paclitaxel (Taxol) is safe and appears to renew paclitaxel response in some patients with refractory advanced ovarian cancer, Abbie L. Fields, MD, said in an ASCO poster presentation of the preliminary results of the phase II study.
Hereditary Pancreatic Cancer: Part II. Candidate Genes
July 1st 1997This special series on cancer and genetics is compiled and edited by Henry T. Lynch, MD, director of the Hereditary Cancer Institute, professor of medicine, and chairman of the Department of Preventive Medicine and Public Health, Creighton University School of Medicine, and director of the Creighton Cancer Center, Omaha, Nebraska. Part I of this three-part series on pancreatic cancer appeared in June 1997. Part II (below) reviews the gene mutations thought to contribute to the development of hereditary pancreatic cancer, and Part III will explores the clinical recognition of a hereditary predisposition to pancreatic cancer.
Recent Progress in Radioimmunotherapy for Cancer
July 1st 1997Radioimmunotherapy allows for the delivery of systemically targeted radiation to areas of disease while relatively sparing normal tissues. Despite numerous challenges, considerable progress has been made in the application of radioimmunotherapy to a wide variety of human malignancies. The greatest successes have occurred in the treatment of hematologic malignancies. Radioimmunotherapy, with or without stem-cell transplant support, has produced substantial complete remission rates in chemotherapy-resistant B-cell lymphomas. Nonmyeloablative regimens have shown so much promise that they are now being tested as initial therapy for low-grade B-cell lymphomas. Although solid tumor malignancies have been less responsive to radioimmunotherapy, encouraging results have been obtained with locoregional routes of administration, especially when the tumor burden is small. Greater tumor-to-normal tissue ratios are achievable with regional administration. Even with intraperitoneal and intrathecal administration, bone marrow suppression remains the dose-limiting toxicity. Ongoing research into new targeting molecules, improved chelation chemistry, and novel isotope utilization is likely to extend the applications of this strategy to other tumor types. The potential for radioimmunotherapy will be enhanced if this modality can be optimally adapted for integration with other agents and if the administration method can be tailored to the type and distribution of malignancy. [ONCOLOGY 11(7):979-987, 1997]
Update on Hepatic Intra-Arterial Chemotherapy
July 1st 1997Theoretically, effective regional cancer chemotherapy should afford the opportunity to deliver a significantly higher concentration of a cytotoxic agent than is possible with systemic administration of the same agent. Furthermore, regional chemotherapy should cause its greatest stress on the site of administration, producing a lesser burden of toxicity on the whole body.
New Drugs May Brighten Ovarian Cancer Picture
June 1st 1997With its poor prognosis, ovarian cancer remains a disease in search of definitive treatment. Although paclitaxel (Taxol) has improved the outlook, advanced ovarian cancer still has a 5-year mortality rate of 65%. The real problem, according to
Researchers Hope Function of BRCA1 Gene Holds Key to New Treatments
June 1st 1997New knowledge about the normal function of the BRCA1 gene, various mutations of which have been shown to cause breast and ovarian cancers, may help researchers develop treatments for both hereditary and sporadic disease. Jeffrey T.
Ovarian Cancer Surgical Practice Guidelines
June 1st 1997The Society of Surgical Oncology surgical practice guidelines focus on the signs and symptoms of primary cancer, timely evaluation of the symptomatic patient, appropriate preoperative evaluation for extent of disease, and role of the surgeon in
Current Challenges of Gene Therapy for Prostate Cancer
June 1st 1997The explosive increase in the apparent incidence of prostate cancer in the United States (which is due, in large measure, to wider efforts at early detection) has been accompanied by a dramatic stage migration, which can also be attributed to the increased use of prostate-specific antigen (PSA).
Non-Cross-Resistant Agents for Ovarian Cancer
April 1st 1997BOCA RATON, Fla--Topotecan (Hycamtin) and other non-cross-resistant drugs appear to be good salvage therapy for patients with recurrent ovarian cancer, Robert F. Ozols, PhD, said at the annual meeting of the Network for Oncology Communication and Research.
Current Role of Protective Agents in Cancer Treatment
April 1st 1997Dr. Schuchter's article explores the theoretical and practical aspects underlying the concept of cytoprotection, which has been recently introduced into the therapeutic armamentarium. Cytoprotection is contrasted with the related strategy of rescue, which has been widely applied since the cytokines granulocyte colony-stimulating factor (G-CSF, filgrastim [Neupogen]) and granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim [Leukine, Prokine]) obtained FDA approval.
Cisplatin/Paclitaxel vs Cisplatin/Teniposide for Advanced Non-Small-Cell Lung Cancer
A total of 332 patients with advanced non-small-cell lung cancer were randomized by the European Organization for Research and Treatment of Cancer Lung Cancer Cooperative
Paclitaxel as First-Line Treatment for Metastatic Breast Cancer
When administered as a single agent in pretreated patients with advanced breast cancer, paclitaxel (Taxol) exhibits remarkable antitumor activity. This trial was undertaken to compare paclitaxel with standard