Neoplasms

All Conditions

Rare Diseases

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Germ Cells Tumors

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Cisplatin

Epirubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Cisplatin plus Epirubicin

Lawrence Einhorn, M.D.

This study proposes to evaluate the combination of cisplatin plus epirubicin in patients with refractory germ cell tumor not amendable to cure with surgery or standard platinum salvage chemotherapy. This regimen will be used in eligible patients after progression on ECOG Study E39897.

To determine the feasibility and toxicity of combining epirubicin to fixed does cisplatin; to determine the partial and complete response rate and duration of remission; to determine the toxicity; to ascertain the potential for greater than 12 month continuous disease-free survival and, therefore, potential curability.

Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors

Phase II Study of Cisplatin Plus Epirubicin Salvage Chemotherapy in Refractory Germ Cell Tumors

Indiana University

Indiana University School of Medicine

Amino Acids

Mitogens

Gefitinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

ZD1839 Iressa

Lawrence Einhorn, M

This study will evaluate the use of ZD1839 in the treatment of subjects with refractory germ cell tumors. Subjects will take ZD1839 for one year in the absence of excessive toxicity or decision to withdraw.

The primary objective is to determine the response rate of ZD1839 in patients with refractory germ cell tumors expressing EGFR. The secondary objectives are to determine the duration of response, time to progression and overall survival in patients with refractory germ cell tumors expressing EGFR and treated with ZD1839; to evaluate the tolerability of ZD1839 in patients with refractory germ cell tumors and to correlate tumor response to degree of EGFR expression by immunohistochemistry.

A Phase II Study of Iressa in Patients With Chemo Refractory Germ Cell Tumors Expressing EGFR

A Phase II Study of ZD1839 (Iressa)in Chemotherapy Refractory Germ Cell Tumors Expressing Epidermal Growth Factor Receptor (EGFR)

AstraZeneca

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urogenital Diseases

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.

50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.

Sunitinib Malate

Lance Pagliaro, MD, BA

The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248) can control the disease in patients with germ cell tumors that are resistant to earlier treatment.

The Study Drug:

Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer.

Within 14 days of enrollment on this study, you will have the following tests and procedures performed:

* Your complete medical history will be recorded.
* You will have a physical exam.

Within 7 days of enrollment on this study, you will have the following tests and procedures performed:

-Blood (about 3 teaspoons) and urine will be collected for routine testing and to test for certain biomarkers (to check the status of the disease).

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take sunitinib malate capsules once a day (by mouth) for 4 weeks in a row followed by 2 weeks with no study drug. These 6 weeks are considered 1 cycle of study treatment.

Study Visits:

On Day 1 of each cycle (about every 6 weeks), you will have the following tests done before you take the study drug:

* You will have a physical exam.
* You will be asked about how you are feeling and about any side effects you have experienced since your last visit.
* You will have blood (about 3 teaspoons) and urine collected for routine tests and to test for certain biomarkers.

For the first 4 weeks of treatment, you should have your blood pressure monitored. This may be done at your home with a digital pressure device, or you may visit your local doctor for this testing.

About Day 21 of Cycles 1 and 2, blood (about 2- 3 teaspoons) will be drawn for routine tests. This may be done at your local doctor's office and results faxed to the study doctor.

On Day 1 of Cycle 2, Day 1 of Cycle 3, and then Day 1 of every 2 cycles after that (Cycle 5, Cycle 7, and so on), you will have imaging scans to check status of the disease. This could include CT or MRI scans, an ECG, and a chest x-ray. If your doctor thinks it is necessary, you may have additional imaging scans at any time.

On Day 1 of every other cycle (Cycle 3, Cycle 5, and so on), you will have an echocardiogram or MUGA scan.

Length of Study:

You may remain on study for as long as you are benefitting. You will be taken off study if intolerable side effects occur or if the disease gets worse. However, if the disease gets worse very quickly during Cycles 1 or 2, you will be taken off study at that time.

Off-Study Visit:

When you are taken off of treatment on this study, the following tests and procedures will be performed:

* You will have a physical exam.
* You will be asked how you are feeling and about any changes in your medical history since beginning this study.
* You will also be asked about any side effects you have experienced since your last visit.

This is an investigational study. Sunitinib malate is approved by the FDA for the treatment of adults with kidney cancer. Its use in patients with germ cell tumors is investigational. Up to 42 patients will take part in this study. All will be enrolled at M. D. Anderson.

Sunitinib Malate in Refractory Germ Cell Tumors

Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors

Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

Pfizer

M.D. Anderson Cancer Center

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Lance Pagliaro, MD/Genitourinary Medical Oncology

12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors	NCT00198172	Germ Cell Tumor	Cisplatin plus ...	15 Years -	Indiana University
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors	NCT00198172	Germ Cell Tumor	Cisplatin plus ...	15 Years -	Indiana University
A Phase II Study of Iressa in Patients With Chemo Refractory Germ Cell Tumors Expressing EGFR	NCT00198159	Refractory Germ...	ZD1839 Iressa	15 Years -	Indiana University
Sunitinib Malate in Refractory Germ Cell Tumors	NCT00912912	Genitourinary D...	Sunitinib Malat...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for refractory germ cell tumors