Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	Over 18	NCI	DMS-9933 NCI-G01-1933, NCT00014456

Objectives

1. Determine the maximum tolerated dose of docetaxel in combination with gemcitabine and filgrastim (G-CSF) in patients with advanced solid tumors.
2. Determine the dose-limiting toxicity associated with this regimen in these patients.
3. Assess the objective anti-tumor response in patients treated with this regimen.
4. Determine fatigue and blood cytokines in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed advanced solid tumor that is not curable by surgery or radiotherapy
  • Sarcoma
  • Melanoma
  • Carcinoma of unknown primary
  • Pancreatic cancer
  • Lung cancer
  • Ovarian cancer
  • Breast cancer
  • Bladder cancer
  • Gastric cancer
  • Esophageal cancer
  • Prostate cancer
  • Head and neck cancer



• No hematopoietic or lymphoid tumors



• Measurable or evaluable disease

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• At least 2 weeks since prior cytotoxic anti-tumor therapy (4 weeks for nitrosourea or mitomycin) and recovered
• No prior docetaxel or gemcitabine

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 2 weeks since prior radiotherapy and recovered

Surgery:

• Not specified

Patient Characteristics:

Age:

• Over 18

Performance status:

• Karnofsky 60-100%
• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm³
• Platelet count greater than 100,000/mm³

Hepatic:

• Bilirubin normal
• AST and/or ALT no greater than 5 times upper limit of normal (ULN) if alkaline phosphatase no greater than ULN

  OR

• Alkaline phosphatase no greater than 5 times ULN if AST and ALT no greater than ULN

  OR

• AST and/or ALT no greater than 1.5 times ULN if alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 2 times ULN

  OR

• Creatinine clearance at least 50 mL/min

Cardiovascular:

• No congestive heart failure
• No unstable angina

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No uncontrolled infection
• No known sensitivity to E. coli-derived products

Expected Enrollment

A maximum of 30 patients will be accrued for this study within 15-22 months.

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.

Trial Contact Information

Trial Lead Organizations

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Konstantin Dragnev, MD, Protocol chair		Ph: 603-650-6345; 800-639-6918 Email: konstantin.dragnev@dartmouth.edu

Registry Information
Official Title		A Dose-Escalation Trial Of The Combination Of Docetaxel, Gemcitabine And Filgrastim (NEUPOGEN) For The Treatment Of Patients With Advanced Solid Tumors
Trial Start Date		2000-03-22
Registered in ClinicalTrials.gov		NCT00014456
Date Submitted to PDQ		2001-02-16
Information Last Verified		2004-11-22
NCI Grant/Contract Number		P30-CA23108

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