Clinical trial · Interventional

Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors

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

NCT00014456CI-TRIAL-00011943completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (12)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Bladder Cancer	Malignant Bladder Neoplasm	CURATED_EXACT	0.92
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Carcinoma of Unknown Primary	Carcinoma of Unknown Primary	ONTOLOGY_EXACT	0.98
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92
Gastric Cancer	Malignant Gastric Neoplasm	CURATED_BROADER	0.80
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Melanoma (Skin)	Melanoma	ONTOLOGY_EXACT	0.85
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
docetaxel	Drug	Docetaxel	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
gemcitabine hydrochloride	Drug	Gemcitabine	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (2)

measure
Determine the maximal tolerated dose of docetaxel in combination with gemcitabine given intravenously every 2 weeks with pegfilgrastim support
timeFrame
Four years
measure
Define dose limiting adverse events associated with the combination
timeFrame
Four years

Secondary outcomes (1)

measure
Objective antitumor response
timeFrame
Four years

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTDragnev 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: 10.1159/000313526. Epub 2010 Apr 20. PMID 20407240

Registry

Dates and enrollment