Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Heart and Blood Diseases

Rare Diseases

Uterine Cervical Neoplasms

Syndrome

Recurrence

Esophageal Neoplasms

Carcinoma

Cholangiocarcinoma

Breast Neoplasms

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Pleural Effusion

Prostatic Neoplasms

Thyroid Neoplasms

Thyroid Cancer, Papillary

Thyroid Diseases

Stomach Neoplasms

Carcinoma, Renal Cell

Neoplasm Metastasis

Adenocarcinoma, Follicular

Lung Neoplasms

Pleural Effusion, Malignant

Urinary Bladder Neoplasms

Vaginal Neoplasms

Vulvar Neoplasms

Liver Neoplasms

Breast Neoplasms, Male

Testicular Neoplasms

Thyroid Carcinoma, Anaplastic

Anus Neoplasms

Adrenocortical Carcinoma

Carcinoma, Adenoid Cystic

Carcinoid Tumor

Carcinoma, Medullary

Pericardial Effusion

Inflammatory Breast Neoplasms

Carcinoma, Islet Cell

Insulinoma

Gastrinoma

Carcinoma, Mucoepidermoid

Mucoepidermoid Tumor

Glucagonoma

Zollinger-Ellison Syndrome

Somatostatinoma

Esophageal Cancer

Pancreatic Cancer

Papillary Thyroid Carcinoma

Bile Duct Cancer

Renal Cell Carcinoma

Thyroid Cancer, Follicular

Stomach Cancer

Vaginal Cancer

Primary Liver Cancer

Gallbladder Cancer

Breast Cancer, Male

Germ Cells Tumors

Anaplastic Thyroid Cancer

Anal Cancer

Transitional Cell Cancer of the Renal Pelvis and Ureter

Vulvar Cancer

Small Intestinal Adenocarcinoma

Adenoid Cystic Carcinoma

Thyroid Cancer, Medullary

Testicular Germ Cell Tumor

Inflammatory Breast Cancer

Small Intestine Cancer

Urethral Cancer

Parathyroid Carcinoma

Mucoepidermoid Carcinoma

WDHA Syndrome

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Gastrointestinal Agents

Herbal and Botanical

Trastuzumab

Liver Extracts

Parathyroid Hormone

Tipifarnib

Pancreatic Polypeptide

Antineoplastic Agents, Immunological

Cola

Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.

trastuzumab

tipifarnib

Anthony W. Tolcher, MD

Phase I trial to study the effectiveness of trastuzumab plus R115777 in treating patients who have advanced or metastatic cancer. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with R115777 may kill more tumor cells.

OBJECTIVES:

I. Determine the maximum tolerated dose of R115777 when administered with trastuzumab (Herceptin) in patients with advanced or metastatic adenocarcinoma.

II. Assess the toxicities and pharmacokinetics of this treatment regimen in this patient population.

III. Determine the antitumor activity of this treatment regimen in these patients.

IV. Determine the relative biologic endpoints of this regimen and correlate them with toxicity and pharmacokinetic parameters in these patients.

OUTLINE: This is a dose escalation, multicenter study of R115777.

Patients receive trastuzumab (Herceptin) IV over 90 minutes on days 1, 8, 15, and 22 plus oral R115777 twice daily for 3 weeks. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose limiting toxicities.

Patients are followed every 30 days until toxicity resolves.

Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer

A Phase I, Pharmacokinetic, and Biologic Correlative Study of R115777 (NSC 702818) and Herceptin in Patients With Advanced Cancer

National Cancer Institute (NCI)

Nervous System Diseases

Glioblastoma

Pheochromocytoma

Head and Neck Neoplasms

Glioma

Sarcoma

Brain Neoplasms

Mesothelioma

Mesothelioma, Malignant

Central Nervous System Neoplasms

Medulloblastoma

Nervous System Neoplasms

Astrocytoma

Ependymoma

Oligodendroglioma

Gliosarcoma

Glioma, Subependymal

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Adenoma

Neoplasms, Mesothelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Adrenal Cortex Neoplasms

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cortex Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Soft Tissue Sarcoma

Malignant Mesothelioma

Brain Tumor, Adult

Brain Tumor, Childhood

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Diffuse Astrocytoma

Childhood Brain Stem Glioma

Pilocytic Astrocytoma

Medulloblastoma, Childhood

Anaplastic Ependymoma

Cerebellar Astrocytoma, Childhood

Cerebral Astrocytoma, Childhood

Subependymoma

Myxopapillary Ependymoma

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

Bone Density Conservation Agents

Anticoagulants

Anti-Infective Agents

Other Dietary Supplements

Tamoxifen

Doxorubicin

Liposomal doxorubicin

Cisplatin

Citric Acid

Sodium Citrate

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

Citrate

cisplatin

doxorubicin hydrochloride

tamoxifen citrate

conventional surgery

radiation therapy

Stan Z. Gertler, MD, FRCPC

RATIONALE: Drugs used in chemotherapy, such as cisplatin and doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Estrogen can stimulate the growth of tumor cells. Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen. Combining tamoxifen with chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cisplatin and doxorubicin together with tamoxifen works in treating patients with solid tumors.

OBJECTIVES:

* Determine the feasibility and efficacy of cisplatin, doxorubicin, and tamoxifen (CAT) in patients with soft tissue sarcoma, glioma, mesothelioma, hepatoma, thyroid cancer, or adrenal cancer.
* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive cisplatin IV over 1-2 hours followed immediately by doxorubicin IV over 15-30 minutes on days 1-3 and oral tamoxifen twice daily on days 4-17. Treatment continues every 3 weeks in the absence of the total cumulative doxorubicin dose reaching at least 500 mg/m2, disease progression, or unacceptable toxicity. Patients who achieve partial remission (PR) undergo local surgery or radiotherapy, if feasible, to convert PR to complete remission.

Patients are followed every 2 months for 1 year and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study.

Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors

Cisplatin, Doxorubicin and Tamoxifen in the Treatment of Incurable Soft Tissue and Endocrine Malignancies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer	NCT00005842	Cancer	trastuzumab tipifarnib	18 Years -	National Cancer Institute (NCI)
Combination Chemotherapy and Tamoxifen in Treating Patients With Solid Tumors	NCT00002608	Adrenocortical ... Brain and Centr... Head and Neck C... Liver Cancer Malignant Mesot... Pheochromocytom... Sarcoma	cisplatin doxorubicin hyd... tamoxifen citra... conventional su... radiation thera...	- 65 Years	National Cancer Institute (NCI)
Tumor Necrosis Factor in Patients Undergoing Surgery for Primary Cancer or Metastatic Cancer	NCT00436410	Adrenocortical ... Breast Cancer Colorectal Canc... Gastrointestina... Kidney Cancer Liver Cancer Melanoma (Skin) Ovarian Cancer Pancreatic Canc... Sarcoma	colloidal gold-... electron micros... pharmacological... conventional su...	18 Years -	National Institutes of Health Clinical Center (CC)
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer	NCT00005842	Cancer	trastuzumab tipifarnib	18 Years -	National Cancer Institute (NCI)
Antineoplaston Therapy in Treating Patients With Stage IV Adrenal Gland Cancer	NCT00003453	Stage IV Adreno...	Antineoplaston ...	6 Months - 99 Years	Burzynski Research Institute
S9427, Suramin in Treating Patients With Stage III or Stage IV Adrenocortical Cancer Incurable by Surgery	NCT00002921	Adrenocortical ...	suramin therapeutic hyd...	18 Years -	SWOG Cancer Research Network
Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery	NCT00848016	Recurrent Adren... Stage III Adren... Stage IV Adreno...	R-(-)-gossypol ...	18 Years -	National Cancer Institute (NCI)
IMC-A12 With Mitotane vs Mitotane Alone in Recurrent, Metastatic, or Primary ACC That Cannot Be Removed by Surgery	NCT00778817	Recurrent Adren... Stage III Adren... Stage IV Adreno...	IMC-A12 mitotane	18 Years -	National Cancer Institute (NCI)
Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery	NCT00848016	Recurrent Adren... Stage III Adren... Stage IV Adreno...	R-(-)-gossypol ...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for stage iv adrenocortical carcinoma