| Genitourinary
Trials |
| TITLE |
E 1804: Phase II Trial of Sorafenib (BAY43-9006)
(IND 69896; NSC 724772) in Patients with Advanced Urothelial Cancer
|
| DESCRIPTION |
This study will evaluate the 4-month progression-free survival rate, response rate and toxicity of BAY 43-9006 in patients with
progressing regional or metastatic transitional cell carcinoma. BAY 43-9006 will be administered at a dose of 400 mg (2 tablets) orally
twice daily (every 12 hours) (total daily dose: 800 mg)(one cycle = 8 weeks). |
| ELIGIBILITY |
- Age ≥ 18 years
- Histologically confirmed transitional cell carcinoma or mixed histologies containing a component of transitional cell carcinoma of
the urothelium with manifestations of progressing regional or metastatic cancer OR non-transitional histologies including adenocarcinoma or
squamous cell carcinomas representing greater than 90% of the tumor
- Patients must have progressed on one and only one prior systemic chemotherapy for metastatic disease.
- Must not have had prior biologic response modifier therapy
- ECOG performance status of 0 or 1.
- Patients must have normal bone marrow, liver and kidney function.
- No history of severe cardiovascular disease
- Must not be on therapeutic anticoagulation
|
| CONTACT |
Sue Bergant RN 216-844-7012 |
| TITLE |
GLAX 1805: A Phase II Study of GW786034 Using a Randomized Discontinuation Design in Subjects with Locally Recurrent or
Metastatic Clear-Cell Renal Cell Carcinoma (RCC) |
| DESCRIPTION |
This study will evaluate the safety and effectiveness of GW786034 in adult subjects with locally recurrent or metastatic
clear-cell RCC. Subjects will receive oral GW786034, 800 mg once daily for 12 weeks, starting on Day 1. |
| ELIGIBILITY |
- Age ≥ 21 years
- Histologically or cytologically confirmed diagnosis of renal cell carcinoma of predominantly clear-cell histology which is metastatic or
locally recurrent.
- Either no prior chemotherapy or failed only 1 prior cytokine-based or bevacizumab-based therapy.
- ECOG Performance Status (PS) of 0 or 1.
- Patients must have normal bone marrow, liver and kidney function.
- Must not have received prior cytokine or non-bevacizumab therapies
- No history of hypercalcemia
- No history of cerebrovascular accident
- No brain metastases
|
| CONTACT |
Sue Bergant RN 216-844-7012 |
| TITLE |
E 2805: A Randomized, Double Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell
Carcinoma |
| DESCRIPTION |
This study will determine if either Sunitinib or Sorafenib can prevent recurrence of kidney cancer and compare the effects of
the Sunitinib and the Sorafenib with placebo to see which is better. Patients will take 2 tablets of Sorafenib of placebo twice a day for 6
weeks for approximately one year and 4 capsules of Sunitinib or placebo once a day for 4 weeks followed by a 2 week break for approximately
one year. Patients can be registered before or after surgery. |
| ELIGIBILITY |
- Age > 18 years
- If registered presurgery: Patients must have primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent.
- If registered post surgery: No evidence of residual or metastatic cancer after surgery
- Must be no less than 3 weeks and no more than 10 weeks from surgery at randomization
- Patients with no prior anti-cancer therapy are permitted in either the adjuvant or neoadjuvant setting. This includes metastectomy
for renal cell carcinoma, or radiation therapy to the renal bed
- Patients must have histological or cytological confirmed renal cell carcinoma T1B (Fuhrman grade 3-4), T2, T3 and T4 with N0-2 and
must have undergone a full surgical resection (radical nephrectomy or partial nephrectomy) by either open or laparoscopic technique.
- ECOG performance status 0 2
- Patients must have normal bone marrow, liver and kidney function.
- No pre-existing thyroid abnormalities
|
| CONTACT |
Sue Bergant RN 216-844-7012 |
| TITLE |
SANO 1805: A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARDŽ- leuprolide acetate) in
Combination with TAXOTEREŽ (docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the
Same Therapeutic Options in Patients with Prostate Cancer at High Risk of Relapse After Radical Prostatectomy |
| DESCRIPTION |
This study aims to determine the long-term survival of patients. In addition, the objective of the study is also to compare if
the combination of TaxotereŽ (a chemotherapy drug) with EligardŽ (hormonal therapy) is more efficient than and as safe as EligardŽ alone.
Patients will receive, either around 2 months after surgery or later, 6 courses of chemotherapy with TaxotereŽ and 6 courses of hormone therapy with EligardŽ or 6 courses of EligardŽ only. |
| ELIGIBILITY |
- Pathologically confirmed adenocarcinoma of the prostate based on central pathology review.
- Patients have undergone a radical prostatectomy.
- No bone or lung metastases
- No prior systemic treatment for prostate cancer with hormonal therapy, chemotherapy or any other anticancer treatment. No prior radiation
- Serum testosterone > 150 ng/dL
- ECOG performance status ≤1
- Age ≥ 18 years
- Patients must have normal bone marrow, liver and kidney function.
|
| CONTACT |
Sue Bergant RN 216-844-7012 |
| TITLE |
ICC 1802: Cytokine Genotypes and Risk of Depression Syndromes in Patients Undergoing Radiotherapy for Prostate Cancer, and Efficacy of Treatment with Bupropion |
| DESCRIPTION |
The purpose of this study is to: 1) measure the number of men who get symptoms of depression during radiotherapy for prostate cancer, and 2) understand who is more likely to get depression symptoms during radiotherapy, and to treat the symptoms if they occur |
| ELIGIBILITY |
- Age 18-75, able to informed consent
- Initiating radiation therapy alone, either external beam or brachytherapy, for localized carcinoma of the prostate, without associated chemotherapy
- No significant current neuropsychiatric diagnoses or current psychiatric treatment
- No current immunotherapy or immunosuppressant treatment, hematologic malignancy or other immunologic disorder
|
| CONTACT |
Duare Valenzuela 216-844-5390 |
| TITLE |
S
9346:Intermediate Androgen
Deprivation in Patients
With Stage D2 Prostate
|
| DESCRIPTION |
This
study is designed around the use of combination hormone
therapy with an LHRH analogue and an antiandrogen. Induction
therapy consists of combined androgen deprivation for 8 cycles
of treatment (7 months). Consolidation consists of a
randomization to one of two treatment arms: continuous
hormonal therapy or intermittent hormonal therapy. This study
will assess whether patients randomized to the intermittent
combined androgen therapy arm have survival that is not
substantially worse than patients randomized to the continuous
combined androgen therapy arm. |
| ELIGIBILITY
|
-
Histologically or cytologically proven diagnosis of
adenocarcinoma of the prostate.
-
Patients who have already begun the use of combined
androgen deprivation therapy with LHRH agonist and
antiandrogen may be eligible for late induction
registration.
-
Registering institution must us the Hybritech or Abbott
PSA assays.
-
Must have an elevated PSA > 5 ng/ml within 56
days prior to registration.
-
Patients with a history of prior neoadjuvant or adjuvant
hormone therapy must have received four or less months of
hormone treatment. Must not have received finasteride
unless treatment was administered for nine months or less.
All therapy must have been discontinued more than a year
prior to registration.
-
Must not have had a bilateral orchiectomy.
-
Must not have acute cord compression.
-
Performance status 0-2 by SWOG criteria.
|
| CONTACT |
Ann Ness, RN
216-844-1637
|
|
|