Know Cancer

forgot password

Phase I Study Of Gemcitabine, Docetaxel And Carboplatin, With And Without Filrastim Support, Combination Chemotherapy In Patients With Advanced Non-Hematological Malignancies

Phase 1
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Phase I Study Of Gemcitabine, Docetaxel And Carboplatin, With And Without Filrastim Support, Combination Chemotherapy In Patients With Advanced Non-Hematological Malignancies

OBJECTIVES: I. Determine the maximum tolerated dose of gemcitabine and docetaxel when
administered with carboplatin with or without filgrastim (G-CSF) in patients with advanced
solid tumors. II. Determine a safe dose level and schedule for this regimen for phase II
study in these patients. III. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of docetaxel and gemcitabine. Patients receive
gemcitabine IV over 30 minutes, docetaxel IV over 1 hour, and carboplatin IV over 30 minutes
on day 1. Patients also receive gemcitabine IV over 30 minutes on day 8. Treatment repeats
every 21 days for approximately 6 courses in the absence of disease progression or
unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine and
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
(DLT). If the DLT is grade 4 neutropenia, filgrastim (G-CSF) is added to the regimen
(administered subcutaneously on days 2-7 and 8-14 or until blood counts recover). A new MTD
is then determined. Patients are followed every 3 months.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed solid tumor for which
no curative therapy exists No symptomatic or uncontrolled brain or leptomeningeal

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC greater than 3,000/mm3 Absolute neutrophil count at least
1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper
limit of normal (ULN) AST no greater than 1.5 times ULN Renal: Creatinine no greater than
ULN Cardiovascular: No unstable cardiac disease requiring treatment No new onset crescendo
or rest angina Stable exertion angina allowed Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use 2 methods of contraception for at least 1 week
prior to study, during study, and for at least 2 weeks after study No symptomatic
peripheral neuropathy greater than grade 1 No significant neurologic or psychiatric
disorders including psychotic disorders, dementia, or seizures No other significant
medical or psychiatric condition that would preclude study No active infection No other
malignancy within past 5 years except non-melanoma skin cancer, carcinoma in situ of the
cervix, or other cancer that, due to its stage, is highly unlikely to recur during
treatment No known hypersensitivity to E. coli-derived products

PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent prophylactic hematopoietic
growth factors (i.e., filgrastim (G-CSF) or sargramostim (GM-CSF)) Chemotherapy: No more
than 1 prior chemotherapy regimen for advanced disease At least 3 weeks since prior
chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Prior cisplatin,
carboplatin, docetaxel, paclitaxel, or gemcitabine allowed No other concurrent
chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy and
recovered Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No
concurrent radiotherapy Surgery: Not specified Other: At least 3 weeks since prior
investigational drugs and recovered No other concurrent experimental agents No other
concurrent anti-cancer therapy No concurrent prophylactic oral or IV antibiotics without
fever present

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Chandra P. Belani, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh


United States: Federal Government

Study ID:




Start Date:

March 1998

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms



University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213