|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Norris Cotton Cancer Center National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00014456 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have advanced solid tumors.
| Condition | Intervention | Phase |
|
Bladder Cancer Breast Cancer Carcinoma of Unknown Primary Esophageal Cancer Gastric Cancer Head and Neck Cancer Lung Cancer Melanoma (Skin) Ovarian Cancer Pancreatic Cancer Prostate Cancer Sarcoma |
Drug: docetaxel Drug: filgrastim Drug: gemcitabine hydrochloride |
Phase I |
| Genetics Home Reference related topics: | bladder cancer breast cancer |
| ChemIDplus related topics: | Filgrastim Docetaxel Gemcitabine hydrochloride Gemcitabine Salicylsalicylic acid Sodium salicylate |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Dose-Escalation Trial Of The Combination Of Docetaxel, Gemcitabine And Filgrastim (NEUPOGEN) For The Treatment Of Patients With Advanced Solid Tumors |
| Study Start Date: | March 2000 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of docetaxel.
Patients receive docetaxel IV over 1 hour followed by gemcitabine IV over 30 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously daily beginning on day 2 and continuing until blood counts recover. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Fatigue is assessed at baseline and then at weeks 2, 5, 7, and 9 during therapy.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 15-22 months.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed advanced solid tumor that is not curable by surgery or radiotherapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, New Hampshire | |||||
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |||||
| Lebanon, New Hampshire, United States, 03756-0002 | |||||
| Norris Cotton Cancer Center |
| National Cancer Institute (NCI) |
| Study Chair: | Konstantin H. Dragnev, MD | Norris Cotton Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068545, DMS-9933, NCI-G01-1933 |
| First Received: | April 10, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00014456 |
| Health Authority: | United States: Federal Government |
|
|
|
|
|
|