Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Irinotecan

Cisplatin

Erlotinib Hydrochloride

Topoisomerase I Inhibitors

Enzyme Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Induction (with Erlotinib X 3 cycles) -\> CCRT with Erlotinib (X 2 cycles) -\> continue Erlotinib (X 6 cycles)

Induction (IP X 3 cycles) -\> CCRT with IP (X 2 cycles)

CCRT with IP (X 2 cycles) -\> consolidation IP (X 3 cycles)

Induction (Erlotinib X 3 cycles) -\> CCRT with IP (X 2 cycles) -\> recurrence -\> Erlotinib (until PD)

Erlotinib 150 mg p.o. daily x21 days every 3 weeks

Erlotinib

Irinotecan 65mg/m2 + Cisplatin 30mg/m2 IV on D1,D8 every 3 weeks X 3 cycles

Induction or consolidation IP chemotherapy

Irinotecan (60mg/m2) + cisplatin (30mg/m2) IV on D1 \& 8 every 3 weeks X 2 cycles

CCRT with IP chemotherapy (Irinotecan + Cisplatin)

CCRT :Concurrent Thoracic Radiotherapy (2.4 Gy/fr, Total 60 Gy, 25fr over 5 weeks)

CCRT

Sung JIn Yoon, Rn

Jin Soo Lee, M.D.

Heung Tae Kim, M.D.

Ji-Youn Han, M.D.

Geon Kook Lee, M.D.

Tak Yun, M.D.

Kwan Ho Cho, M.D.

Hong Ryull Pyo, M.D.

Bin Hwangbo, M.D.

Hee Seok Lee, M.D.

Kun young Lim, M.D.

Kyong-Ah Yoon, PH.D.

Byung-Ho Nam, Ph.D.

Young Ho Yun, M.D.

Jae-ill Zo, M.D.

The use of induction chemotherapy is feasible and effective. It is also logistically beneficial for decreasing micrometastases and radiation-related toxicity by decreasing tumor burden before definite locoregional concurrent therapy. Previously the investigators conducted several phase II study of IP chemotherapy in advanced NSCLC and demonstrated that IP chemotherapy has a promising activity and readily manageable toxicity profile. Given the encouraging activity of IP chemotherapy in the advanced stage setting, the investigators postulated that their further investigation in the stage III setting might lead to further prolongation of survival times. In addition to cisplatin, Irinotecan has been demonstrated to act as radiation sensitizers in preclinical and clinical setting. Therefore, their use with concurrent radiotherapy might lead to radiation sensitization and improved locoregional control.

Concurrent Chemoradiation therapy is widely accepted as a standard treatment of locally advanced unresectable stage III NSCLC. When compared with the result of radiation therapy alone of CALGB 8433 trial (i.e., 9.7 months), the median survival times have almost doubled over the last 2 decades, but rarely exceeded 18 months after chemoradiation therapy in most randomized trials. On the other hand, a significant portion of patients had to endure the side effects of grade 3/4 esophagitis and also pneumonitis, which resulted in treatment-related deaths in some cases. There is a great need to develop more effective but less toxic treatment strategies. Recently, molecular-targeted therapy using EGFR-TKIs brought new enthusiasm to the NSCLC therapy. The investigators observed a median survival time of 20.1 months in chemo-naïve never-smoker Korean patients with adenocarcinoma of the lung. The benefit of EGFR-TKI was also demonstrated in never-smokers who participated in the phase III trial of carboplatin/paclitaxel with or without Erlotinib (TRIBUTE). Despite a lack of benefit in the overall patient population, Erlotinib conferred a survival benefit to those who had never smoked cigarettes, In this analysis, 105 patients who were identified as never smokers had a median survival of 10 months, similar to the entire study population, when treated with carboplatin/paclitaxel plus placebo. However, for the patients in this subpopulation who were treated with Erlotinib and the same chemotherapy regimen, the median survival increased to 22.5 months (P = 0.01). Furthermore, EGFR mutation was associated with significantly higher response rate and longer survival as compared with those without EGFR mutation. More importantly, the median survival time of those patients with EGFR mutation-positive tumors exceeded 20 months in the majority of the studies. These results are very provocative given the fact that only the patients with stage IIIb not amenable to chemoradiation therapy and stage IV NSCLC patients were included in the study and in many studies, the majority of the patients were heavily pre-treated with multiple chemotherapy regimens. The investigators postulate that if the case were properly selected, EGFR-TKI would significantly improve the overall survival of the patients with locally advanced unresectable stage III NSCLC. The investigators therefore propose a randomized phase II trial to evaluate the efficacy and toxicity of EGFR-TKI Erlotinib in selected group of NSCLC patients with EGFR mutation-positive stage III tumors. The use of induction chemotherapy is feasible and effective. It is also logistically beneficial for decreasing micrometastases and radiation-related toxicity by decreasing tumor burden before definite locoregional concurrent therapy. Previously the investigators conducted several phase II study of IP chemotherapy in advanced NSCLC and demonstrated that IP chemotherapy has a promising activity and readily manageable toxicity profile. Given the encouraging activity of IP chemotherapy in the advanced stage setting, the investigators postulated that their further investigation in the stage III setting might lead to further prolongation of survival times. In addition to cisplatin, Irinotecan has been demonstrated to act as radiation sensitizers in preclinical and clinical setting. Therefore, their use with concurrent radiotherapy might lead to radiation sensitization and improved locoregional control.

Induction Chemotherapy Followed by CCRT According to EGFR Mutation Status in NSCLC III

A Randomized Phase II Study of Induction Chemotherapy Followed by Concurrent Chemoradiation Therapy According to EGFR Mutation Status in Patients With Unresectable Stage III NSCLC

Roche Pharma AG

Pfizer

National Cancer Center, Korea

President

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinosarcoma

Mixed Tumor, Mullerian

Adenoma, Pleomorphic

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Sarcoma

Neoplasms, Connective and Soft Tissue

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Malignant Mixed Mullerian Tumor

Ovarian Carcinosarcoma

Soft Tissue Sarcoma

Paclitaxel

Bevacizumab

Albumin-Bound Paclitaxel

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Initial Treatment Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)

Consolidation Treatment:

Avastin 15mg/kg IV every 21 days x 12 cycles

Avastin

Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles

75mg/m2 IP day 2 every 21 days x 6 cycles

D. Scott McMeekin, MD

The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.

Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.

Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.

Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer

Phase II Study of Paclitaxel (TAXOL), Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer

Genentech, Inc.

University of Oklahoma

Avastin: Initial Treatment:

Paclitaxel 135mg/m2 IV Day 1 every 21 days x 6 cycles, Cisplatin 75mg/m2 IP Day 2 every 21 days x 6 cycles, Bevacizumab 15mg/kg Day 1 IV every 21 days x 5 cycles (beginning with cycle 2)

Consolidation Treatment:

Avastin 15mg/kg IV every 21 days x 12 cycles

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Ingrid Block, CTO Director

Number of Patients Able to Complete 6 Cycles of Treatment.

Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.

Overall Study

Small Cell Lung Carcinoma

Small Cell Lung Cancer

Lipid Regulating Agents

Simvastatin

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Irinotecan/cisplatin (IP) chemotherapy

* Cisplatin(30 mg/m2) diluted into 150 ml of 0.9% NS for IV over 30 min on day 1 \&8.
* Irinotecan(65mg/m2) diluted into 200ml of 5DW IV over 90 min on day 1 \& 8
* Every 21 days

IP chemotherapy

* Cisplatin(30mg/m2)diluted into 150 ml of 0.9% NS for IV over 30 min on day 1 \&8
* Irinotecan( 65 mg/m2) diluted into 200ml of 5DW IV over 90 min on day 1\& 8.
* Every 21days.
* Simvastatin 40 mg per day orally D1of cycle 1

IP chemotherapy plus simvastatin

JI-YOUN HAN, M.D. PhD.

The purpose of this study is to compare the efficacy of Simvastatin and Irinotecan/Cisplatin chemotherapy with Irinotecan/Cisplatin chemotherapy alone in Extensive disease-small cell lung cancer.

Statins (3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors) have been used to treat hypercholesterolemia. Besides the lipid lowering effects, they also act as anti-inflammatory and anti-cancer agents. Recently the investigators demonstrated a synergistic cytotoxicity between Simvastatin and Irinotecan in human lung cancer cells. Simvastatin enhances Irinotecan-induced apoptosis by inhibition of proteasome activity. All of these additional actions may counteract harmful effects of smoking-induced chronic inflammation. These properties together with a high safety profile have made Statins more attractive drug for small cell lung cancer (SCLC), the highly smoking-related cancer.

Given the promising preclinical anti-tumor and anti-inflammatory effects of Simvastatin in SCLC, recently the investigators conducted a phase II study of Simvastatin and Irinotecan/Cisplatin (IP) chemotherapy in chemo-naïve- patients with Extensive disease-small cell lung cancer (ED-SCLC). The 1-year survival rate was 39.3%. The median overall survival (OS) and progression free survival (PFS) was 11.0 months and 6.1 months, respectively. Overall relative risk (RR) was 75%. The most common toxicity was neutropenia (67%). The efficacy was significantly associated with smoking-status. Compared with never-smokers, ever-smokers had higher RR (40% v 78%, P=0.01) and longer PFS (2.5 months v 6.4 months, P=0.018) and showed a trend toward improved OS (9.0 months v 11.2 months, P=0.095). The effect of smoking on survival was apparent when subdividing ever smokers according to pack-years (PY). Ever-smokers who smoked \> 65 PY showed significantly longer OS compared to ever-smokers who smoked \<= 65 PY or never-smokers (20.6 months v 10.6 months v 9.0 months, log-rank P=0.032). In multivariate analysis, PY \> 65 was predictive for longer survival (hazard ratio) HR=0.377 \[95% CI (confidence interval), 0.157-0.905\]). These findings suggest that the addition of Simvastatin to Irinotecan and Cisplatin improved efficacy in ever-smokers with ED-SCLC. The survival benefit of this combination seems apparent in heavy-smokers.

Irinotecan/Cisplatin With or Without Simvastatin in Chemo-naive Patients With Extensive Disease-small Cell Lung Cancer

A Randomized Phase II Study of Irinotecan/Cisplatin With or Without Simvastatin in Chemo-naive Patients With Extensive Disease-small Cell Lung Cancer

Survival time will be calculated from the date of study treatment start to the date of death.( or date last seen ) Follow - up visits are conducted every 8 weeks to obtain meaningful data on time- to event variables. Assessment will continue until death or 12 months after treatment.

The response rate will be determined by the number of patients with complete and partial responses according to RECIST criteria 1.1

Progression free survival will be calculated from the date of study treatment start to the first objective documentation of progressive disease or to the date of death, whichever occurs first.

Safety will be evaluated by the frequency, severity, and relationship of adverse event graded by NCI Common Toxicity Criteria version 4.0 that occur during the treatment and follow up periods.

Head, lung cancer center

Carboplatin

Patients with optimally debulked advanced (stage 3 or 4) epithelial ovarian cancer; IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles

IV Paclitaxel 175mg/m2 + IV Carboplatin (AUC4.5) AT DAY 1; IP Paclitaxel 60 mg/m2 at day 8; every 21 days, 6 cycles

SANG YOUNG RYU, M.D.

Most patients with advanced ovarian cancer suffered recurrences. Therefore, adjuvant therapy is recommended for all patients with advanced ovarian cancer.

Traditionally, intravenous paclitaxel + carboplatin has been the standard adjuvant therapy.

Recently, intraperitoneal combination chemotherapy has been reported to be effective in ovarian cancer.

We attempted to evaluate the efficacy and feasibility of standard intravenous paclitaxel + carboplatin plus intraperitoneal paclitaxel chemotherapy.

Epithelial ovarian cancer is the leading cause of death from gynecologic malignancies worldwide. The recommended treatment includes primary surgery for diagnosis, staging, and cytoreduction, followed by chemotherapy. Epithelial ovarian cancer is more sensitive to cytotoxic drugs than other solid tumors, most patients with advanced ovarian cancer are recommended treatment with postoperative adjuvant chemotherapy. The recommended initial chemotherapy is generally platinum and taxane combination given by intravenous infusion every 3 weeks for 6 courses. This treatment resulted in complete remission in about 50% of ovarian cancer patients and pathologic complete response in 25\~30% of patients.

However most patients with advanced ovarian cancer suffered recurrences after primary treatment, median progression free survival is 15.5-22months, and median overall survival is about 31-44months.

As residual ovarian cancer after surgery and initial recurrences are primarily confined to the abdomen, intraperitoneal administration of chemotherapy was proposed several decades ago. In 2006, Armstrong, et al., reported improvement of overall survival in ovarian cancer patient with optimal surgical debulking followed intraperitoneal paclitaxel + cisplatin chemotherapy. The National Cancer Institute (NCI) of the United States recommended to consider intraperitoneal chemotherapy in optimally debulking patients.

In Korea, however, there are few studies about postoperative adjuvant intraperitoneal chemotherapy in optimally debulked (residual mass \<1cm) advanced ovarian cancer patients.

Therefore the investigators tend to evaluate the efficacy and feasibility of postoperative adjuvant intraperitoneal chemotherapy. (standard intravenous paclitaxel+carboplatin plus intraperitoneal paclitaxel chemotherapy)

Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer

Phase II Clinical Trial of Intravenous Paclitaxel and Carboplatin Plus Intraperitoneal Paclitaxel as an Adjuvant Chemotherapy in Patients With Optimally Debulked Advanced Epithelial Ovarian Carcinoma

The time from randomization to the time of disease progression as determined by the investigator or death from any cause.

Progression is diagnosed by imaging or serial tumor marker elevation.

Median observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol

The time from randomization to the time of disease progression as determined by the investigator (by clinical, radiological or pathological means) or death from any cause

Observed length of life from entry into the study to death; or for living patients, the date of last contact regardless of whether or not this contact is on a subsequent protocol.

Korea Cancer Center Hospital

Chair of Cerivcal/Ovarian Cancer Center

Symptoms and General Pathology

Immune System Diseases

Recurrence

Hypersensitivity

Uterine Neoplasms

Fallopian Tube Neoplasms

Fallopian Tube Diseases

Uterine Diseases

There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy

Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles

Paclitaxel, Cisplatin IP

Joan Walker, MD

The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen (belly) along with intravenous administration.

Giving chemotherapy directly into the abdomen is called intraperitoneal (IP) chemotherapy. Because ovarian, fallopian, primary peritoneal and uterine cancer spread in the abdominal cavity, giving chemotherapy drugs by infusion into the abdominal cavity may result in a greater dose of the drugs reaching the tumor cells. Intraperitoneal treatments will be administered through an implantable peritoneal catheter. These catheters are to be inserted into the peritoneal cavity, tunneled through the subcutaneous tissue, and connected to an implantable port, which is placed in the subcutaneous tissue of the anterior, inferior thorax.

Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

Feasibility Trial of Intraperitoneal Chemotherapy in Stage IA, IB, IC, II, III, IV and Recurrent Platinum Sensitive Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma and Stage III and IV Uterine Cancer

There is only one arm for this study and it represents the participants receiving the intraperitoneal chemotherapy

Paclitaxel, Cisplatin IP: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Induction Chemotherapy Followed by CCRT According to EGFR Mutation Status in NSCLC III	NCT00620269	Lung Cancer NSCLC	Erlotinib Induction or co... CCRT with IP ch... CCRT	18 Years -	National Cancer Center, Korea
Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer	NCT00511992	Advanced Ovaria... Primary Periton... Ovarian Carcino...	Avastin Paclitaxel Cisplatin	18 Years -	University of Oklahoma
Irinotecan/Cisplatin With or Without Simvastatin in Chemo-naive Patients With Extensive Disease-small Cell Lung Cancer	NCT01441349	Small Cell Lung...	IP chemotherapy IP chemotherapy...	18 Years -	National Cancer Center, Korea
Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer	NCT00511992	Advanced Ovaria... Primary Periton... Ovarian Carcino...	Avastin Paclitaxel Cisplatin	18 Years -	University of Oklahoma
Irinotecan/Cisplatin With or Without Simvastatin in Chemo-naive Patients With Extensive Disease-small Cell Lung Cancer	NCT01441349	Small Cell Lung...	IP chemotherapy IP chemotherapy...	18 Years -	National Cancer Center, Korea
Efficacy Study of Additional Intraperitoneal Chemotherapy to Treat Ovarian Cancer	NCT00919984	Ovarian Neoplas...	IP chemotherapy	20 Years - 75 Years	Korea Cancer Center Hospital
Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma	NCT00582205	Ovarian Cancer Fallopian Tube ... Primary Periton... Uterine Cancer	Paclitaxel, Cis...	18 Years - 99 Years	University of Oklahoma
Induction Chemotherapy Followed by CCRT According to EGFR Mutation Status in NSCLC III	NCT00620269	Lung Cancer NSCLC	Erlotinib Induction or co... CCRT with IP ch... CCRT	18 Years -	National Cancer Center, Korea

Spots Global Cancer Trial Database for ip chemotherapy