NCT00176280

Brief Summary

  • Overall study design: A randomized Phase II study in patients with metastatic RCC Patients will receive chemotherapy with gemcitabine and 5-FU. Prior to each chemotherapy the patient will receive a combination of Leukine alone (study cohort 1) or Leukine-dexamethasone (study cohort 2).
  • Chemotherapy: gemcitabine 1.0 g/m2 intravenously (infused in the vein)over 30 minutes on Days 7 and 21, Folinic acid 200 mg/m2 on Days 7-8 and 21-22, then 5-FU 400 mg/m2, intravenously (infused in the vein) over 30 minutes followed by 5-FU 600 mg/m2 intravenously (infused in the vein) over 24 hours.
  • Study drugs:
  • Cohort 1, Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin) on days 1, 2, 3, 4, 5 and 15, 16, 17, 18, and 19;
  • Cohort 2, Leukine, 250 ug/m2 daily (8 am) subcutaneously (under the skin)on days 1, 2, 3, 4, 5, and 15, 16, 17, 18, and 19 and dexamethasone 12 mg every 12 hours (8 am and 8 pm) orally (by mouth) on days 3, 4, 5, 6, 7, 17, 18, 19, 20, and 21.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

June 18, 2015

Status Verified

June 1, 2015

First QC Date

September 9, 2005

Last Update Submit

June 16, 2015

Conditions

Renal Cell Carcinoma

Keywords

RenalCarcinomaRenal Cell CarcinomaRCCLeukineDexamethasoneGemcitabine5 Fluorouracil5 FUMetastatic

Outcome Measures

Primary Outcomes (4)

  • % of subjects with CR or PR evaluated after course 2 then every other course using RECIST for both cohorts

  • Survival (assessed until death)

  • QOL (evaluated after courses 3 & 5 then every other course)

  • % of subjects with >/= grade 3 hematopoietic & non-hematopoietic toxicities (assessed 3/week on treatment & continuing until counts recover)

Secondary Outcomes (2)

  • Days with <AGC 500 & platelet (PLC)< 20K mm3, # of febrile neutropenia hospital days, # of transfusions, bleeding & # of outpatient antibiotic days (assessed 3/week on treatment then until counts recover)

  • Levels of peripheral blood dendritic cell # & function, plasma levels of cytokines including VEGF & TNF alpha (performed on days 1 & 7 of treatment)

Interventions

LeukineDRUG
DexamethasoneDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically proven, metastatic RCC. Patients may have either recurrent or primary Stage IV or unresectable regionally advanced disease.
  • Previous surgery (nephrectomy), immunotherapy with IL-2, IFN-a or other cytokines and anti-angiogenic therapy are allowed but all therapy must have been completed four weeks prior to entry into this study.
  • Previous radiation therapy is allowed if completed at least four weeks prior to study entry and therapy was administered to \< 25% of the bone marrow.
  • Patients must be \>18 years of age (age limit required by the State of Kentucky). Women of childbearing potential must have a negative pregnancy test and must be willing to consent to using effective contraception while on treatment and for a reasonable period thereafter. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Patients must have ECOG PS 0,1 or 2.
  • Patients must have at least one target lesion according to the RECIST criteria. Bone metastases, leptomeningeal disease, ascites, pleural or pericardial effusions, lymphangitic spread or cystic lesions are not acceptable as target lesions.
  • Patients must have an expected survival of at least four months.
  • Patients must have adequate organ and marrow function as defined as follows: leukocytes \>3,000/mm3, absolute neutrophil count \>1,500/mm3, hemoglobin \>8.0g/dl, platelets \>100,000/mm3, total bilirubin and serum creatinine must be \< 1.5 mg/dl. Liver transaminases (SGOT and/or SGPT) may be up to 2.5 institutional upper limit of normal (ULN) if alkaline phosphatase is \<ULN or alkaline phosphatase may be up to 4 ULN if transaminases are \<ULN.
  • Patients must have the ability to understand and the willingness to sign a written informed consent document. Patients have the right to withdraw from the study at any time, without prejudice.

You may not qualify if:

  • Patients with previous history of cancer are excluded unless they have had curative treatment completed \>5 years prior to entry onto study or have one of the following: in situ carcinoma (any location), basal cell carcinoma, or non-metastatic squamous cell carcinoma of the skin.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled or untreated cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients requiring any non study corticosteroids for any reason are excluded.
  • Pregnant women are excluded from this study because of the teratogenic potential of 5-FU and gemcitabine. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Lactating women are also excluded. Post menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Patients may not be receiving any other investigational agents.
  • Peripheral neuropathy must be ≤ grade 1.
  • Patients with a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be significant enough to preclude informed consent or interfering with compliance for oral drug intake are excluded.
  • Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery.
  • Participation in any investigational drug study within 4 weeks preceding treatment start.
  • Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome or inability to swallow tablets.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Renal CellCarcinomaNeoplasm Metastasis

Interventions

sargramostimDexamethasone

Condition Hierarchy (Ancestors)

AdenocarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • John Rinehart, MD

    University of Kentucky

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

September 1, 2005

Last Updated

June 18, 2015

Record last verified: 2015-06