Randomized Phase 2 Trial of Pre-chemotherapy Leukine vs. Leukine-Dexamethasone in Combination With Gemzar & 5-FU in Patients With Metastatic Renal Cell Carcinoma

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kentucky
• Collaborator: Bayer
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fluorouracil; Gemcitabine; Sargramostim

Criteria

Inclusion Criteria:

1. Patients must have histologically proven, metastatic RCC. Patients may have either recurrent or primary Stage IV or unresectable regionally advanced disease.

2. 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.

3. 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.

4. 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.

5. Patients must have ECOG PS 0,1 or 2.

6. 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.

7. Patients must have an expected survival of at least four months.

8. 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 isULN if transaminases are

9. 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.

Exclusion Criteria:

1. 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.

2. 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.

3. Patients requiring any non study corticosteroids for any reason are excluded.

4. 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.

5. Patients may not be receiving any other investigational agents.

6. Peripheral neuropathy must be ≤ grade 1.

7. 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.

8. Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from major surgery.

9. Participation in any investigational drug study within 4 weeks preceding treatment start.

10. Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome or inability to swallow tablets.