Combination Chemotherapy Plus Filgrastim in Treating Patients With Advanced Solid Tumors
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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: | 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 |
| Study Start Date: | March 2000 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
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 |
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| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| 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: | January 8, 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 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 |
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 Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Respiratory Tract Neoplasms |
ClinicalTrials.gov processed this record on May 23, 2013