Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00014456
First received: April 10, 2001
Last updated: August 27, 2013
Last verified: August 2013
  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 combination chemotherapy plus filgrastim in treating patients who have advanced solid tumors.


Condition Intervention Phase
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
Biological: filgrastim
Drug: docetaxel
Drug: gemcitabine hydrochloride
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dose-Escalation Trial Of The Combination Of Docetaxel, Gemcitabine And Filgrastim (NEUPOGEN) For The Treatment Of Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Determine the maximal tolerated dose of docetaxel in combination with gemcitabine given intravenously every 2 weeks with pegfilgrastim support [ Time Frame: Four years ] [ Designated as safety issue: Yes ]
  • Define dose limiting adverse events associated with the combination [ Time Frame: Four years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective antitumor response [ Time Frame: Four years ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: March 2000
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014456

Locations
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Study Chair: Konstantin H. Dragnev, MD Norris Cotton Cancer Center
  More Information

Additional Information:
Publications:
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00014456     History of Changes
Other Study ID Numbers: D9933, P30CA023108, DMS-9933, NCI-G01-1933
Study First Received: April 10, 2001
Last Updated: August 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Dartmouth-Hitchcock Medical Center:
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

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Breast Neoplasms
Carcinoma
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
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Respiratory Tract Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014