Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer

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.

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Key information

Conditions

Cancer Adenocarcinoma Adenocarcinoma, Follicular Adenocarcinoma, Papillary Adenoma Adenoma, Islet Cell Adrenal Cortex Diseases Adrenal Cortex Neoplasms Adrenal Gland Diseases Adrenal Gland Neoplasms Adrenocortical Carcinoma Anus Diseases Anus Neoplasms Appendiceal Neoplasms Bile Duct Diseases Bile Duct Neoplasms Biliary Tract Diseases Biliary Tract Neoplasms Brain Diseases Brain Neoplasms Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Islet Cell Carcinoma, Medullary Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Cecal Diseases Cecal Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gallbladder Diseases Gallbladder Neoplasms Gastrinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glucagonoma Gonadal Disorders Head and Neck Neoplasms Inflammatory Breast Neoplasms Insulinoma Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Meningeal Carcinomatosis Meningeal Neoplasms Mouth Diseases Mouth Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Unknown Primary Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors Neuroendocrine Tumors Pancreatic Diseases Pancreatic Neoplasms Parathyroid Diseases Parathyroid Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pleural Diseases Pleural Effusion Pleural Effusion, Malignant Pleural Neoplasms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Skin Diseases Skin and Connective Tissue Diseases Somatostatinoma Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Testicular Diseases Testicular Neoplasms Thoracic Neoplasms Thyroid Cancer, Papillary Thyroid Carcinoma, Anaplastic Thyroid Diseases Thyroid Neoplasms Urethral Diseases Urethral Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms Vipoma Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Brooke Army Medical Center, Fort Sam Houston, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed advanced or metastatic adenocarcinoma
Expression of +1 to 3+ HER2/neu on immunohistochemical or immunocytochemistry staining
No brain metastases unless all of the following is true:

Previously treated
Asymptomatic
Stable dose of decadron
No evidence of edema

PATIENT CHARACTERISTICS:

Age: 18 and over
Performance status: ECOG 0-2
Life expectancy: At least 12 weeks
Absolute granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3
Hemoglobin at least 9.0 g/dL
Bilirubin no greater than 1.5 mg/dL
AST/ALT no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver involvement)
Creatinine no greater than 1.5 mg/dL
LVEF at least 50% by RVG or MUGA
No uncontrolled unstable angina
No history of congestive heart failure or cardiac ischemia
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No concurrent active infection or serious systemic disorder that would preclude study
No allergies to imidazole compounds

PRIOR CONCURRENT THERAPY:

No prior trastuzumab (Herceptin) No other concurrent immunotherapy
At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered
No other concurrent chemotherapy
No concurrent hormonal cancer therapy except LHRH agonists for prostate cancer
No concurrent radiotherapy
No other concurrent experimental medications

Treatment and study plan

trastuzumab

Biological

tipifarnib

Drug

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

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

Important dates

Study start: 2000
Primary completion: 2004
First posted: Apr 26, 2004
Registry last updated: Feb 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed