Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014456
• Other study ID #: D9933
• Secondary ID: P30CA023108DMS-9
• Status: Completed
• Phase: Phase 1
• First received: April 10, 2001
• Last updated: August 27, 2013
• Start date: March 2000
• Est. completion date: October 2005

Study information

• Verified date: August 2013
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bladder Cancer
• Breast Cancer
• Carcinoma
• Carcinoma of Unknown Primary
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Melanoma (Skin)
• Neoplasms, Unknown Primary
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostate Cancer
• Prostatic Neoplasms
• Sarcoma
• Stomach Neoplasms
• Urinary Bladder Neoplasms

Intervention

Biological:
• filgrastim

Drug:
• docetaxel

• gemcitabine hydrochloride

Locations

Country	Name	City	State
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dragnev KH, Hardin SB, Pipas JM, Davis TH, Rigas JR. A dose escalation trial of biweekly docetaxel and gemcitabine with filgrastim or pegfilgrastim for the treatment of patients with advanced solid tumors. Chemotherapy. 2010;56(2):135-41. doi: 10.1159/000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the maximal tolerated dose of docetaxel in combination with gemcitabine given intravenously every 2 weeks with pegfilgrastim support		Four years	Yes
Primary	Define dose limiting adverse events associated with the combination		Four years	Yes
Secondary	Objective antitumor response		Four years	No