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| 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 |
Biological: filgrastim Drug: docetaxel Drug: gemcitabine hydrochloride |
Phase I |
| 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 | |
| Study Chair: | Konstantin H. Dragnev, MD | Norris Cotton Cancer Center |
More Information
| Study ID Numbers: | CDR0000068545, DMS-9933, NCI-G01-1933 |
| Study First Received: | April 10, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00014456 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer stage IV gastric cancer recurrent gastric cancer metastatic osteosarcoma recurrent non-small cell lung cancer stage II pancreatic cancer stage III pancreatic cancer recurrent pancreatic cancer stage II esophageal cancer stage III esophageal cancer stage IV esophageal cancer recurrent esophageal cancer chondrosarcoma recurrent adult soft tissue sarcoma |
stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer extensive stage small cell lung cancer recurrent small cell lung cancer recurrent osteosarcoma recurrent bladder cancer stage IV bladder cancer stage IV prostate cancer recurrent prostate cancer stage IV melanoma recurrent melanoma stage IV non-small cell lung cancer stage IV salivary gland cancer recurrent salivary gland cancer classic Kaposi sarcoma |
|
Thoracic Neoplasms Neuroectodermal Tumors, Primitive Prostatic Diseases Pancreatic Neoplasms Urogenital Neoplasms Squamous Cell Carcinoma Urologic Neoplasms Kaposi Sarcoma Docetaxel Neoplasms, Connective and Soft Tissue Carcinoma, Adenoid Cystic Lung Neoplasms Neoplasm Metastasis Osteogenic Sarcoma Neuroepithelioma |
Ovarian Cancer Gemcitabine Salivary Gland Diseases Breast Diseases Endocrine Gland Neoplasms Neoplasms, Unknown Primary Nasopharyngeal Carcinoma Digestive System Neoplasms Urinary Bladder Diseases Genital Neoplasms, Female Urinary Bladder Neoplasms Endocrine System Diseases Breast Neoplasms Esophageal Cancer Carcinoma, Basal Cell |
|
Thoracic Neoplasms Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Prostatic Diseases Pancreatic Neoplasms Physiological Effects of Drugs Urogenital Neoplasms Urologic Neoplasms Docetaxel Neoplasms, Connective and Soft Tissue Pathologic Processes Neoplasms by Site Lung Neoplasms Therapeutic Uses |
Neoplasm Metastasis Gemcitabine Breast Diseases Endocrine Gland Neoplasms Neoplasms, Unknown Primary Digestive System Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Genital Diseases, Male Carcinoma Neuroectodermal Tumors Neoplasms |
