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A Dose-Escalation Trial Of The Combination Of Docetaxel, Gemcitabine And Filgrastim (NEUPOGEN) For The Treatment Of Patients With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

A Dose-Escalation Trial Of The Combination Of Docetaxel, Gemcitabine And Filgrastim (NEUPOGEN) For The Treatment Of Patients With Advanced Solid Tumors


OBJECTIVES:

- Determine the maximum tolerated dose of docetaxel in combination with gemcitabine and
filgrastim (G-CSF) in patients with advanced solid tumors.

- Determine the dose-limiting toxicity associated with this regimen in these patients.

- Assess the objective anti-tumor response in patients treated with this regimen.

- Determine fatigue and blood cytokines in patients treated with this regimen.

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.

Inclusion 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

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/mm^3

- Platelet count greater than 100,000/mm^3

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

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Konstantin H. Dragnev, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Norris Cotton Cancer Center

Authority:

United States: Federal Government

Study ID:

D9933

NCT ID:

NCT00014456

Start Date:

March 2000

Completion Date:

October 2005

Related Keywords:

  • 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
  • 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
  • AIDS-related Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • recurrent metastatic squamous neck cancer with occult primary
  • stage IV ovarian germ cell tumor
  • recurrent ovarian germ cell tumor
  • stage IV uterine sarcoma
  • recurrent uterine sarcoma
  • borderline ovarian surface epithelial-stromal tumor
  • recurrent carcinoma of unknown primary
  • ovarian sarcoma
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent verrucous carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV verrucous carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent lymphoepithelioma of the nasopharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • stage IV lymphoepithelioma of the nasopharynx
  • stage IV squamous cell carcinoma of the nasopharynx
  • recurrent lymphoepithelioma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • recurrent inverted papilloma of the paranasal sinus and nasal cavity
  • recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
  • stage IV inverted papilloma of the paranasal sinus and nasal cavity
  • stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
  • stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
  • recurrent verrucous carcinoma of the oral cavity
  • stage IV verrucous carcinoma of the oral cavity
  • recurrent basal cell carcinoma of the lip
  • stage IV basal cell carcinoma of the lip
  • recurrent mucoepidermoid carcinoma of the oral cavity
  • stage IV mucoepidermoid carcinoma of the oral cavity
  • recurrent adenoid cystic carcinoma of the oral cavity
  • stage IV adenoid cystic carcinoma of the oral cavity
  • stage IV adult soft tissue sarcoma
  • stage IV pancreatic cancer
  • Urinary Bladder Neoplasms
  • Breast Neoplasms
  • Carcinoma
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Melanoma
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Prostatic Neoplasms
  • Neoplasms, Unknown Primary
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002