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Combination Chemotherapy With or Without Filgrastim in Treating Patients With Advanced Solid Tumors
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: UPMC Cancer Centers
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00008125
  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 gemcitabine combined with docetaxel and carboplatin with or without filgrastim in treating patients who have advanced solid tumors.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Drug: carboplatin
Drug: docetaxel
Drug: filgrastim
Drug: gemcitabine hydrochloride
Phase I

MedlinePlus related topics: Cancer
Drug Information available for: Carboplatin Filgrastim Docetaxel Gemcitabine hydrochloride Gemcitabine
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Phase I Study Of Gemcitabine, Docetaxel And Carboplatin, With And Without Filrastim Support, Combination Chemotherapy In Patients With Advanced Non-Hematological Malignancies

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 1998
Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and docetaxel when administered with carboplatin with or without filgrastim (G-CSF) in patients with advanced solid tumors. II. Determine a safe dose level and schedule for this regimen for phase II study in these patients. III. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of docetaxel and gemcitabine. Patients receive gemcitabine IV over 30 minutes, docetaxel IV over 1 hour, and carboplatin IV over 30 minutes on day 1. Patients also receive gemcitabine IV over 30 minutes on day 8. Treatment repeats every 21 days for approximately 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and 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 (DLT). If the DLT is grade 4 neutropenia, filgrastim (G-CSF) is added to the regimen (administered subcutaneously on days 2-7 and 8-14 or until blood counts recover). A new MTD is then determined. Patients are followed every 3 months.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor for which no curative therapy exists No symptomatic or uncontrolled brain or leptomeningeal metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 1.5 times ULN Renal: Creatinine no greater than ULN Cardiovascular: No unstable cardiac disease requiring treatment No new onset crescendo or rest angina Stable exertion angina allowed Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of contraception for at least 1 week prior to study, during study, and for at least 2 weeks after study No symptomatic peripheral neuropathy greater than grade 1 No significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures No other significant medical or psychiatric condition that would preclude study No active infection No other malignancy within past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other cancer that, due to its stage, is highly unlikely to recur during treatment No known hypersensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent prophylactic hematopoietic growth factors (i.e., filgrastim (G-CSF) or sargramostim (GM-CSF)) Chemotherapy: No more than 1 prior chemotherapy regimen for advanced disease At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Prior cisplatin, carboplatin, docetaxel, paclitaxel, or gemcitabine allowed No other concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: Not specified Other: At least 3 weeks since prior investigational drugs and recovered No other concurrent experimental agents No other concurrent anti-cancer therapy No concurrent prophylactic oral or IV antibiotics without fever present

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00008125

Locations
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
UPMC Cancer Centers
Investigators
Study Chair: Chandra P. Belani, MD UPMC Cancer Centers
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000068377, PCI-97-093, PCI-IRB-980207, NCI-G00-1884
Study First Received: January 6, 2001
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00008125  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:
Docetaxel
Carboplatin
Gemcitabine

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009