Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Docetaxel

Cisplatin

Antimetabolites

Tubulin Modulators

Antimitotic Agents

docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15

Docetaxel, Cisplatin

gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15

Gemcitabine, Cisplatin

Chih-Hsin Yang, M.D.,Ph.D.

Ann-Lii Cheng, M.D.,Ph.D.

The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and gemcitabine plus cisplatin followed by weekly docetaxel。

Lung cancer is the leading cause of cancer death in men and women worldwide. Shifting trends in the incidence of lung cancer closely follow the patterns of cigarette smoking, although other carcinogens have been implicated. Despite intensive treatment over the past several decades, the 5-year lung-cancer survival rate remains a dismal 8-14%.

Chemotherapy is the primary therapy to patients with stage IIIB/IV disease, and most investigators believe that treatment with a combination of two agents is the best first-line treatment for stage IV NSCLC. In the late 1970s and 1980s, studies were conducted using combinations of agents. Outcomes were improved and these agents were eventually incorporated into clinical practice.

Weekly docetaxel is being studied in combination with other commonly used NSCLC chemotherapeutic agents including carboplatin, navelbine, and gemcitabine. These combinations are being studied in both first- and second-line settings. Second line chemotherapy with docetaxel may affect survival (TAX 318, 1 year survival 37% vs. 11%). However, the optimal sequence of chemotherapy was rarely explored. Weekly docetaxel may offer better tolerability vs. 3-weekly schedule when combining docetaxel to cisplatin. Based upon these studied, we choose weekly docetaxel in combination with cisplatin as our regimen. We expected the regimen would be effective and well tolerated.

Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)

A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer

National Taiwan University Hospital

Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6

Low RAP expression and any levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Intermediate or high RAP expression and low or intermediate BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6

Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Cisplatin, Docetaxel

Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6

Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Rafel Rossell, MD

Primary objective:

· Progression free survival.

Secondary objectives:

* Assess Overall survival of both treatment groups.
* Assess Tumor response rate using RECIST criteria
* Assess Toxicity profile of patients enrolled in the study.
* Exploratory evaluation of potential genetic markers of response or resistance to chemotherapy.

Study population:

Patients with advanced non-small-cell lung cancer who have not received treatment for the disease at this stage and who have a good performance status (ECOG 0-1) and measurable disease (at least one target lesion according to RECIST criteria).

Duration of treatment:

Six chemotherapy cycles will be given. The duration of every cycle will be 21 days. If the treatment is beneficial, it may be prolonged to a total of 8 cycles at the discretion of the investigator.

Calendar and planned finalization date:

The approximate duration of the study is 3 years of recruitment followed by 1 year of follow-up.

Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma

Multicenter Phase III, Randomized Study to Evaluate Treatment Customized According to RAP80 and BRCA1 Assessment in Patients With Advanced Non-small-cell Lung Cancer

Defined as the length of time from the start of treatment to the date of the first documented progression of disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Defined as the length of time from the start of the treatment that patients diagnosed with the disease are still alive.

Spanish Lung Cancer Group

The drugs used in this trial have been on the market for several years and the profile of safety is known. No unusual AEs has occurred in this trial.

Since the objective of the interim analysis for which the trial was closed was not the analysis of AEs, these have not been analyzed for this trial.

During the study were reported 68 cases of SAEs related to medication and 106 cases of SAEs not related to medication.

The only SUSAR was: Severe afebrile neutropenia and renal failure.

Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6

Cisplatin, Docetaxel: Docetaxel 75 mg/m2 and cisplatin 75 mg/m2, both on day 1, every 21 days. Total number of cycles: 6

Control Group

Low RAP expression and any levels of BRCA1 expression: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Gemcitabine, Cisplatin: Gemcitabine 1250 mg/m2, days 1 and 8, and Cisplatin 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

B1: Experimental Group 1

Intermediate or high RAP expression and low or intermediate BRCA1 expression: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6

Docetaxel, Cisplatin: Docetaxel 75 mg/m2 and Cisplatin 75 mg/m2, both administered on day 1, every 21 days. Total number of cycles: 6

B2 Experimental Group 2

Intermediate or high RAP expression and high BRCA1 expression: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

Docetaxel: Docetaxel 75 mg/m2, day 1. 21-day cycles. Total number of cycles: 6

B3 Experimental Group 3

A Control Group

Include experimental groups Arm B1+ Arm B2+ Arm B3

Experimental Group

Total

Age, Continuous

Sex: Female, Male

Spain

Region of Enrollment

Smoker

Non-smoker

No data

Smoking status

ECOG 0

ECOG 1-2

ECOG Performance Status Scale: It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability

GRADES:

ECOG 0: Fully active. ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature ECOG 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours ECOG 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours ECOG 4: Completely disabled ECOG 5: Dead

ECOG

Thoracic

Extra-thoracic

Stage IV disease extension at study entrance

Squamous

NonSquamous

Histology

Median number of cycles

Low BRCA mRNA level

Intermediate BRCA mRNA level

Hight BRCA mRNA level

The expression of BRCA1 mRNA will be determined by RT- PCR in paraffin-embedded tumor samples

BRCA1 mRNA level

Low RAP80 mRNA level

Intermediate RAP80 mRNA level

Hight RAP80 mRNA level

Undetermined level RAP80 mRNA

The expression of RAP80 mRNA will be determined by RT-PCR in paraffin-embedded tumor samples

RAP 80 mRNA level

mRNA expression by a real-time PCR in paraffin-embedded tumor samples

mRNA RAP80 expression values

mRNA BRCA1 expression values

The were a early closure of the study and it was notified to comply with the regulations for early termination of the studies. clinical trials (futility analysis).

Eva Pereira

This is a futility analysis. The initial hypothesis of the clinical trial was that the experimental group as a whole was superior to the control group.

Progression Free Survival

Overall Survival

Patients with low expression of RAP 80, and with any level of BRCA1 expression:

gemcitabine 1250 mg/m2, days 1 and 8, and cisplatin 75 mg/m2, day 1. Cycles every 21 days.

Experimental Group Arm B1

Patients with intermediate or high expression of RAP 80, and with low or intermediate expression of BRCA1: docetaxel 75 mg/m2, and cisplatin 75 mg/m2, both administered on day 1, every 21 days

Experimental Group Arm B2

Patients with intermediate or high expression of RAP 80, and with high expression of BRCA1: docetaxel 75 mg/m2, day 1. Cycles every 21 days.

Experimental Group Arm B3

Overall Study

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Symptoms and General Pathology

Rare Diseases

Nasopharyngeal Carcinoma

Recurrence

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Docetaxel 35mg/m2 D1 \& D8 Cisplatin 70mg/m2 D1 every 3 weeks maxinum 6 cycles

Docetaxel 35mg/m2 D1 \& D8 Cisplatin 70mg/m2 D1

Myung-Ju Ahn, Pf

The investigators will evaluate weekly docetaxel plus 3-weekly cisplatin regimen as the first-line therapy for recurrent of metastatic nasophayngeal cancer

Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer

Phase II Trial of Cisplatin Plus Weekly Docetaxel as the First-line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

Samsung Medical Center

Myung-Ju Ahn / Professor

Digestive System Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Capecitabine

docetaxel 75 mg/m2, IV on day 1 of each 3 week cycle until progression or unacceptable toxicity develops

docetaxel

docetaxel 60 mg/m2 and cisplatin 60 mg/m2, IV on day 1 of each 3 week cycle until progression or unacceptable toxicity develops

docetaxel, cisplatin

docetaxel 60 mg/m2 IV on day 1 and S-1 30 mg/m2 bid PO on days 1-14 of each 3 week cycle until progression or unacceptable toxicity develops

docetaxel, S-1

Sook Ryun Park, Dr.

Young Lan Park, CRC

Hye-Suk Han, M.D.

Sook Ryun Park, M.D.

Young Lan Park, RN

Noe Kyeong Kim, M.D., Ph.D.

Youngiee Park, M.D., Ph.D.

Byung-Ho Nam, Ph.D.

Dong Bok Shin, M.D., Ph.D.

Sun Jin Sym, M.D.

Keun-Wook Lee, M.D., Ph.D.

The purpose of this study is to assess efficacy and safety of docetaxel alone, docetaxel plus cisplatin, and docetaxel plus S-1 in patients with metastatic gastric cancer after failing 1st line chemotherapy with cisplatin plus S-1 or capecitabine

To date, the most commonly used first-line chemotherapies have been based on fluorouracil and/or cisplatin in patients with metastatic gastric cancer. Unfortunately, considerable proportions of patients with metastatic gastric cancer do not respond to first-line chemotherapy and most of the patients who do respond eventually experience disease progression. In the second-line treatment, however, standard therapies are less clearly defined.

Meanwhile, regarding re-challenge of previous failed drugs as a combination with an other newly introduced chemotherapeutic agent, there are few data. Increased expression and activity of thymidylate synthase, which is inhibited by fluoropyrimidine, is regarded to be the main reason for the development of clinical resistance to fluoropyrimidine. Since the cotreatment of docetaxel and 5-fluorouracil decreases the activity and expression of thymidylate synthase and dihydropyrimidine dehydrogenase (5-fluorouracil degradation enzyme), and increases the expression of orotate phosphoribosyl transferase, the addition of docetaxel into S-1 may recover the sensitivity to S-1 in patients previously resistant to S-1.

Several reports found that MDR-1 and MRP-1 are related to cisplatin-resistance; cisplatin induces the overexpression of MRP-1, which reduces intracellular cisplatin accumulation. Since docetaxel suppresses the cisplatin-induced MRP-1 upregulation, the addition of docetaxel into cisplatin may recover the sensitivity to cisplatin in patients previously resistant to cisplatin.

Based on these synergism mechanisms, we speculate that the cotreatment of docetaxel and cisplatin or S-1 has better anti-tumor activity than docetaxel alone in patients resistant to cisplatin or S-1.

Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer

A Randomized Phase II Study of Docetaxel vs. Docetaxel Plus Cisplatin vs. Docetaxel Plus S-1 as Second-line Chemotherapy After Cisplatin Plus S-1 or Capecitabine in Metastatic Gastric Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)	NCT00173888	Non-small Cell ...	Docetaxel, Cisp... Gemcitabine, Ci...	18 Years - 75 Years	National Taiwan University Hospital
Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma	NCT00617656	Non Small Cell ... BRCA1 Mutation	Cisplatin, Doce... Gemcitabine, Ci... Docetaxel, Cisp... Docetaxel	18 Years -	Spanish Lung Cancer Group
Weekly Docetaxel Plus Cisplatin as the First-line Therapy for Nasopharyngeal Cancer	NCT01312311	Nasopharyngeal ...	Docetaxel, Cisp...	18 Years -	Samsung Medical Center
Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer	NCT00980603	Gastric Cancer	docetaxel docetaxel, cisp... docetaxel, S-1	18 Years -	National Cancer Center, Korea
Study to Evaluate Treatment Customized According to RAP80 and BRCA1 in Patients With Advanced Lung Carcinoma	NCT00617656	Non Small Cell ... BRCA1 Mutation	Cisplatin, Doce... Gemcitabine, Ci... Docetaxel, Cisp... Docetaxel	18 Years -	Spanish Lung Cancer Group

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