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)

Heart Diseases

Pharmaceutical Solutions

Anti-Infective Agents

Bleomycin

Sclerosing Solutions

Anti-Bacterial Agents

Antibiotics, Antitubercular

Procedure/Surgery: Observation alone after pericardial drainage

Drug: Pericardial instillation of bleomycin after drainage

Observation alone after pericardial drainage

Pericardial instillation of bleomycin after drainage

Tomohide Tamura, MD

The purpose of this study is to evaluate the efficacy of pericardial instillation of bleomycin as a sclerosing agent after pericardial drainage for lung cancer-associated malignant pericardial effusion.

Malignant pericardial effusions (MPEs), which are commonly associated with cardiac tamponade, make oncologic emergencies requiring prompt drainage. In lung cancer patients, MPE is one of the most unpleasant terminal events. Drainage usually results in prompt palliation of symptoms, but recurrent effusions often occur. Sclerosis with pericardial instillation of various agents is reported to prevent the recurrence, and bleomycin is the most commonly used drug, with fewer toxicities compared with others. There is, however, no prospective trial of pericardial sclerosis as compared with drainage alone for MPEs, and it is far from clear whether sclerosis really benefits these patients in terminal stages.

Comparison: Intra-pericardial instillation of bleomycin after pericardial drainage versus drainage alone for MPEs caused by lung cancer.

Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion

A Randomized Controlled Trial to Evaluate the Efficacy of Intra-pericardial Instillation of a Sclerosing Agent After Pericardial Drainage in Patients With Malignant Pericardial Effusion Associated With Lung Cancer (JCOG9811)

Ministry of Health, Labour and Welfare, Japan

Japan Clinical Oncology Group

Tomohide Tamura , MD

Adenocarcinoma of Lung

Carcinoma, Adenosquamous

Adenocarcinoma, Bronchiolo-Alveolar

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pleural Diseases

Respiratory Tract Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Adenocarcinoma

Amino Acids

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Erlotinib Hydrochloride

Tubulin Modulators

Antimitotic Agents

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Patients receive erlotinib hydrochloride PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive erlotinib hydrochloride as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of treatment, patients may continue to receive erlotinib hydrochloride alone as above.

Erlotinib

Pasi A Janne

This randomized phase II trial studies how well erlotinib hydrochloride with or without carboplatin and paclitaxel works in treating patients with stage III-IV non-small cell lung cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving erlotinib hydrochloride together with carboplatin and paclitaxel may kill more tumor cells than giving either drug alone.

PRIMARY OBJECTIVES:

I. To determine the distribution of progression-free survival (PFS) in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) (erlotinib hydrochloride) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

SECONDARY OBJECTIVES:

I. To determine the radiographic response rate in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

II. To determine the frequency of epidermal growth factor receptor (EGFR) and V-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (K-ras) mutations and anaplastic lymphoma kinase (ALK) translocations in patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers.

III. To determine the response rate and time to progression in patients with and without EGFR mutations treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

IV. To determine the response rate and time to progression in patients with and without K-ras mutations treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

V. To determine the median and overall survival of patients with previously untreated advanced adenocarcinoma of the lung who are never or light former smokers treated with either OSI-774 (erlotinib) alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

VI. To estimate the response rate, progression-free, and overall survival of patients with echinoderm microtubule associated protein like (EML)4-ALK translocation who received OSI-774 erlotinib alone (arm A) or in combination with carboplatin/paclitaxel (arm B).

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive erlotinib hydrochloride as in Arm I. Patients also receive paclitaxel intravenously (IV) over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. After completion of 6 cycles of treatment, patients may continue to receive erlotinib hydrochloride alone as above.

After completion of study treatment, patients are followed at least every 3 months for 1 year and then every 6 months for up to 2 years.

Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer

A Phase II Randomized Study of OSI-774 (Erlotinib) (NSC #718781) With or Without Carboplatin/Paclitaxel in Patients With Previously Untreated Adenocarcinoma of the Lung Who Never Smoked or Were Former Light Smokers

Overall survival (OS) is defined as the time from patient randomization (arm assignment) to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method.

PFS was defined as the time from registration until disease progression or death, whichever occurs first. The median PFS with 95% CI was estimated using the Kaplan-Meier method. Progression is defined as in the primary outcome measure.

EGFR mutations were performed at the Dana-Farber Cancer Institute using a sensitive heteroduplex method coupled with enzymatic digestion as previously reported (Janne PA, et al: A rapid and sensitive enzymatic method for epidermal growth factor receptor mutation screening. Clin Cancer Res 12:751-758, 2006). All positive findings were independently verified and subjected to sequencing. The mutation analyses were blinded to the participants' clinical outcome.

Response and EGFR mutation status are defined in previous outcome measures.

Progression free survival is defined in previous outcome measures. GIven the small number of KRAS mutant participants, the analysis combines data from both arms.

Overall response is defined in previous outcome measures. GIven the small number of KRAS mutant participants in each treatment arm, the analysis combines data from both arms.

The product limit estimator developed by Kaplan Meier will be used to graphically describe progression free survival for patients randomized to each study arm.

The 18 week progression-free survival rate was defined as the proportion of patients that were alive progression-free 18 weeks after registration into the study. Disease progression was assessed per modified RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions, in either primary or nodal lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of new lesions. Kaplan-Meier estimate of 18-week progression-free survival was calculated.

The proportion of patients who respond (completely or partially) to each combination regimen will be estimated. An exact binomial confidence interval will be computed for these estimates.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST) criteria:

Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions

The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.

Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death.

Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Arm A: Erlotinib

Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.

Arm B: Erlotinib/Carboplatin/Paclitaxel

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

0 - fully active

1 - minimal symptoms

Classifies patients according to their functional impairment. Scores range from 0 (fully active) to 5 (death).

ECOG Performance Status

Never smoker

Light former smoker

Smoking history

Bronhioloalveolar cancer

Adenocarcinoma with bronchioloalveolar features

Histology

Pasi Janne, MD, PhD

18 Weeks Progression Free Survival (PFS) Rate

Overall Response Rate

Number of Participants With Grade 3, 4 or 5 Adverse Event at Least Possibly Related to Treatment.

Overall Survival

EGFR Mutant

EGFR Wild Type

EGFR mutation analysis was successfully performed in 164 participants; 17 participants had insufficient material or DNA for analysis.

Progression Free Survival (PFS) by Epidermal Growth Factor Receptor (EGFR) Mutation Status

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)
Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion	NCT00132613	Malignant Peric...	Observation alo... Pericardial ins...	- 75 Years	Japan Clinical Oncology Group
Erlotinib Hydrochloride With or Without Carboplatin and Paclitaxel in Treating Patients With Stage III-IV Non-small Cell Lung Cancer	NCT00126581	Lung Adenocarci... Lung Adenosquam... Malignant Peric... Malignant Pleur... Minimally Invas... Stage IIIB Lung... Stage IV Lung N...	Carboplatin Erlotinib Erlotinib Hydro... Paclitaxel	18 Years -	National Cancer Institute (NCI)
QUILT-2.013: A Trial of AMG 479 or AMG 102 in Combination With Platinum-based Chemotherapy as First-Line Treatment for Extensive Stage Small Cell Lung Cancer	NCT00791154	Lung Cancer Small Cell Lung... Solid Tumors Extensive-stage...	AMG 479 Etoposide Placebo AMG 102 Carboplatin Cisplatin	18 Years -	NantCell, Inc.
Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer	NCT02132884	Malignant Peric... Malignant Pleur... Recurrent Non-s... Stage IIIB Non-... Stage IV Non-sm...	cytology specim... therapeutic pro... targeted therap... laboratory biom...	-	Fox Chase Cancer Center
Trastuzumab Plus R115777 in Treating Patients With Advanced or Metastatic Cancer	NCT00005842	Cancer	trastuzumab tipifarnib	18 Years -	National Cancer Institute (NCI)
ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment	NCT00005645	Fallopian Tube ... Metastatic Canc... Ovarian Cancer Primary Periton...	ILX-295501	18 Years - 120 Years	Sanofi
Trial of Drainage With or Without Bleomycin Instillation for Malignant Pericardial Effusion	NCT00132613	Malignant Peric...	Observation alo... Pericardial ins...	- 75 Years	Japan Clinical Oncology Group

Spots Global Cancer Trial Database for malignant pericardial effusion