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	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific	Drug: carboplatin  Drug: docetaxel  Drug: filgrastim  Drug: gemcitabine	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

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

--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

--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

Pennsylvania
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213,  United States

Study chairs or principal investigators

Chandra Prakash Belani,  Study Chair,  University of Pittsburgh Cancer Institute   

Study ID Numbers:  CDR0000068377; PCI-97-093; NCI-G00-1884; PCI-IRB-980207
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00008125
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08