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Sponsors and Collaborators: |
Roswell Park Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003569 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as dimesna may protect normal cells from the side effects of chemotherapy.
PURPOSE: This phase I trial is studying the side effects and best dose of dimesna in treating patients with solid tumors who are receiving cisplatin and paclitaxel.
Condition | Intervention | Phase |
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Head and Neck Cancer Lung Cancer Neurotoxicity Ovarian Cancer |
Drug: cisplatin Drug: dimesna Drug: paclitaxel |
Phase I |
Study Type: | Observational |
Official Title: | Phase I Trial of Escalating Doses of BNP7787 in Patients With Solid Tumors Undergoing Treatment With Cisplatin and Taxol |
Study Start Date: | March 1998 |
OBJECTIVES:
OUTLINE: This is a dose-escalation, two-stage, multicenter study.
During stage I, patients receive a single dose of dimesna IV over 15 minutes 7 days prior to chemotherapy.
Patients then receive paclitaxel IV over 3 hours followed by dimesna IV over 15-30 minutes followed immediately by cisplatin IV over 1 hour on day 1 every 3 weeks. Patients continue courses of paclitaxel, dimesna, and cisplatin every 3 weeks in the absence of disease progression or unacceptable toxicity for up to 6 courses.
In stage I, cohorts of 3-6 patients each receive escalating doses of dimesna until the maximum tolerated dose (MTD) is reached. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT). The MTD of dimesna is then used in stage II of the study, in which the volume of pre and post cisplatin intravenous saline hydration is reduced in cohorts of 3-6 patients each. The MTD intensity of cisplatin is defined as the least saline hydration volume at which no more than 1 of 6 patients experience DLT.
PROJECTED ACCRUAL: Approximately 35 patients will be accrued into this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637-1470 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 |
Study Chair: | Patrick J. Creaven, MBBS, PhD | Roswell Park Cancer Institute |
Study ID Numbers: | CDR0000066635, RPCI-DS-9739, BIONUM-BNP7787IV101, NCI-G98-1478 |
Study First Received: | November 1, 1999 |
Last Updated: | May 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00003569 History of Changes |
Health Authority: | United States: Federal Government |
stage III non-small cell lung cancer recurrent non-small cell lung cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer stage IV non-small cell lung cancer stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx |
stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity neurotoxicity recurrent salivary gland cancer stage IV salivary gland cancer salivary gland squamous cell carcinoma stage III salivary gland cancer |
Thoracic Neoplasms Neurotoxicity Syndromes Laryngeal Carcinoma Gonadal Disorders Disorders of Environmental Origin Urogenital Neoplasms Ovarian Diseases Squamous Cell Carcinoma Hypopharyngeal Cancer Genital Diseases, Female Cisplatin Respiratory Tract Diseases Lung Neoplasms Ovarian Cancer Salivary Gland Diseases |
Endocrine Gland Neoplasms Nasopharyngeal Carcinoma Ovarian Neoplasms Genital Neoplasms, Female Poisoning Endocrine System Diseases Antimitotic Agents Ovarian Epithelial Cancer Recurrence Carcinoma Radiation-Sensitizing Agents Paclitaxel Lung Diseases Head and Neck Neoplasms Tubulin Modulators |
Thoracic Neoplasms Molecular Mechanisms of Pharmacological Action Neurotoxicity Syndromes Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Disorders of Environmental Origin Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Respiratory Tract Diseases Cisplatin Lung Neoplasms Therapeutic Uses |
Endocrine Gland Neoplasms Respiratory Tract Neoplasms Ovarian Neoplasms Mitosis Modulators Nervous System Diseases Genital Neoplasms, Female Poisoning Endocrine System Diseases Antimitotic Agents Pharmacologic Actions Adnexal Diseases Neoplasms Radiation-Sensitizing Agents Paclitaxel Lung Diseases |