Know Cancer

or
forgot password

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

Thank you

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 CenterLebanon, New Hampshire  03756-0002