Neoplasms

All Conditions

Rare Diseases

Osteosarcoma

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Gemcitabine

Docetaxel

Antimetabolites

Tubulin Modulators

Antimitotic Agents

Drug and schedule

* Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min (D1, D8)
* Docetaxel 35 mg/m2 IV (D1, D8) .. every 21 days

Dose modification

* Treatment should be delayed if the ANC\<1,500/ mm3, or if the platelet count \<75,000/mm3 on the first day of the next cycle.
* Gemcitabine \& docetaxel are omitted on day 8, when ANC is less than 1000/mm3 or platelet count is less than 50,000/mm3; it is reduced by 25% if the ANC is between 1,000 and 1,500/mm3 or the platelet count is between 50,000 and 75,000/mm3 Study design Treatment should consist of at least 2 cycles unless rapid disease progression or unacceptable toxicities occur after one cycle of chemotherapy.

Patients with response or no change will receive 2 additional cycles.

Gemcitabine and Docetaxel

Jin-hee Ahn

To determine the activity of weekly Docetaxel and Gemcitabine in patients with advanced soft tissue sarcoma previously treated with anthracycline and/or ifosfamide

1. Primary endpoint: response rate
2. Secondary endpoint: progress-free survival, overall survival, safety

Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy

PhaseⅡ Study of Weekly Docetaxel and Fixed-Dose Rate Gemcitabine in Patient With Previously Treated Advanced Soft Tissue and Bone Sarcoma Prospective, Open Label, Multi-Institutional

Severance Hospital

Korea University Anam Hospital

Samsung Medical Center

Asan Medical Center

Jin-hee Ahn / Associate Professor

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Small Cell

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients received biweekly docetaxel 50 mg/m2 iv, Gemcitabine 2000 mg/m2 iv days 1 and 14.

Docetaxel 50 mg/m2, IV, and Gemcitabine 2000 mg/m2, IV, on day 1 and 14 of each 28 day cycle. Number of Cycles: 6

Oscar Juan, Doctor

Vicente Alberola, Doctor

Francisco Aparisi, Doctor

Gaspar Esquerdo, Doctor

Sonia Maciá, Doctor

Siliva Catot, Doctor

Silvia Catot, Doctor

Alfreso Sánchez, Doctor

Alfredo Sánchez, Doctor

Vicente Marco, Doctor

Vicente Giner, Doctor

Juan L. Martí, Doctor

Antonio López, Doctor

José Gómez, Doctor

Miguel A. Muñoz, Doctor

José muñoz, Doctor

José Muñoz, Doctor

Alfredo Sanchez, Doctor

José Gomez, Doctor

There is little information of Eastern Cooperative Oncology Group (ECOG) performance status (PS) 2 patients analyzed in the clinical trials. The rate of patients recruited into Treatment Chemotherapy as 1st Line in Advanced NSCLC clinical trials is less than 20 percent.

This low rate makes the investigators think about the possibility of a bias selection, due to the existence of this exclusion criteria that do not permit to include patients with deteriorated performance status.

In these types of patients, the toxicity is an important issue to decide the therapeutic strategy. Gemcitabine and Docetaxel combination is very interesting because they have a different toxicity profile. This combination has demonstrated activity in several types of tumours, as breast cancer, sarcoma and lung cancer.

The strategy performed in this study is biweekly combination of Gemcitabine and Docetaxel; activity and dose intensity will be the same, but toxicity will be significantly low.

Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer Patients With ECOG PS 2

Hospital Arnau de Vilanova

Vicente Alberola Candel

Patients in Group 1 will get Gemcitabine 1000 mg/m2 intravenously on Day 1 and Day 8 and Pazopanib 800mg by mouth daily on a 21 day cycle. Cycles will continue until disease progression or patient withdrawal.

Patients in Group 2 will get Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8. Additionally on Day 8, patients will have Docetaxel 100 mg/m2 given intravenously. on a 21 day cycle. If disease progression occurs on this treatment, patients will have the option to receive treatment with Gemcitabine and Pazopanib (group 1).

Gemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle. Pazopanib 800 mg by oral tablet daily for a 21 day cycle.

Gemcitabine and Pazopanib

Gemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle. Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle.

Daniel Y. Reuben, MD

This study is for adult subjects with advanced tissue sarcoma. The study involves the drugs Pazopanib (Votrient), Gemcitabine (Gemzar), and Docetaxel (Taxotere). The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with soft tissue sarcoma.

The purpose of this study is to test the effectiveness and safety of Gemcitabine and Pazopanib compared with Gemcitabine and Docetaxel in participants with soft tissue sarcoma. Screening tests will be done to ensure subjects are eligible to participate in this study. If the exams, tests and procedures show that subjects can be in the study, and they choose to take part, then they will be "randomized" into one of the two study groups: Group 1 or Group 2. Subjects in Group 1 will receive Gemcitabine 1000 mg/m2 intravenously (directly into a vein) on Day 1 and Day 8 and Pazopanib 800mg by mouth daily. Subjects in Group 2 will receive Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8 and Docetaxel 100 mg/m2 intravenously on Day 8. Both groups will be in 21 day cycles. Both groups will be asked to complete "quality of life" questionnaires, on their first visit, then at 6 weeks (2nd cycle), 18 weeks (6th cycle) and at the end of study treatment. Subjects will be followed for up to 2 years.

A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma

A Randomized, Open-label, Phase II, Multi-center Trial of Gemcitabine (G) With Pazopanib (P) or Gemcitabine (G) With Docetaxel (T) in Previously Treated Subjects With Advanced Soft Tissue Sarcoma

To estimate the PFS of the combination of G+P or G+T in patients with metastatic and/or locally advanced or recurrent STS. Progression free survival is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Toxicity is graded according to the CTCAE v 4.

Hazard ratio is defined as the rate of survival in the experimental group versus the standard of care group. A hazard ratio of greater than one or less than one means that survival was better in one of the groups.

To estimate the quality of life of patient with metastatic an/or locally advanced recurrent STS using the Quality of Life Questionnaire (QLQ-C30). The QLQ-C30 is scored on a scale from 0-100 with "0" indicating "never" and "100" indicating "always" in regard the the participants' experience of fatigue, nausea/vomiting, pain, disponae, insomnia, appetite loss, constipation, diarrhea, financial concerns at 4 time points through the study.

Response rate is defined as follows:

Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study

Novartis

Medical University of South Carolina

AE data was collected from subjects at every clinic visit and day 1 of every cycle.

Patients in Group 1 will get Gemcitabine 1000 mg/m2 intravenously on Day 1 and Day 8 and Pazopanib 800mg by mouth daily on a 21 day cycle. Cycles will continue until disease progression or patient withdrawal.

Gemcitabine and Pazopanib: Gemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.

Pazopanib 800 mg by oral tablet daily for a 21 day cycle.

Experimental

Patients in Group 2 will get Gemcitabine 900 mg/m2 intravenously on Day 1 and Day 8. Additionally on Day 8, patients will have Docetaxel 100 mg/m2 given intravenously. on a 21 day cycle. If disease progression occurs on this treatment, patients will have the option to receive treatment with Gemcitabine and Pazopanib (group 1).

Gemcitabine and Docetaxel: Gemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle.

Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle.

Standard of Care

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Cameron Coggins

Average Number of Months of Progression-free Survival

Rate of Participants With Grade 3 or Higher Toxicity

Hazard Ratio

Fatigue at baseline

Nausea/Vommiting at baseline

Pain at baseline

Dysponae at baseline

Insomnia at baseline

Appetite loss at baseline

Constipation at baseline

Diarrhea at baseline

Financial at baseline

Fatigue at cycle 2

Nausea/Vomitting at cycle 2

Pain at cycle 2

Dyspnoae at cycle 2

Insomnia at cycle 2

Appetite loss at cycle 2

Constipation at cycle 2

Diarrhea at cycle 2

Financial at cycle 2

Fatigue at cycle 6

Nausea/vommiting at cycle 6

Pain at cycle 6

Dyspnoae at cycle 6

Insomnia at cycle 6

Appetite loss at cycle 6

Constipation at cycle 6

Diarrhea at cycle 6

Financial at cycle 6

Fatigue at end of study

Nausea/vomitting at end of study

Pain at end of study

Dysponae at end of study

Insomnia at end of study

Appetite loss at end of study

Constipation at end of study

Diarrhea at end of study

Financial at end of study

Average Score of Quality of Life

Response Rate

Overall Study

Skin and Connective Tissue Diseases

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Ifosfamide

Isophosphamide mustard

Mechlorethamine

Antineoplastic Agents, Alkylating

Alkylating Agents

Gemcitabine i.v. 900 mg/m2 in 30 min on day 1 and day 8 every 3 weeks Docetaxel i.v. 75 mg/m2 in 60 min on day 8 every 3 weeks

Ifosfamide i.v. 14 g/m2 continous dose for 14 days every 3 weeks

Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle

Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle

Stefano Ferrari, MD

Phase II randomized study for the comparison of the Gemcitabine plus Docetaxel and the Ifosfamide treatment of patients with relapsed osteosarcoma

Patients with relapsed osteosarcoma will be randomized to receive Gemcitabine plus Docetaxel or High Doses Ifosfamide (continuous infusion) every 3 weeks, up to 6 weeks

Phase II Trial for the Treatment of Relapsed Osteosarcoma

Multicentric, Randomized Phase II Trial for the Treatment of Patients With Relapsed Osteosarcoma

Survival without progression of disease assessed at 6 months from randomization

Rate of tumor response assessed after cycle 2, 4 and 6

From date of starting therapy until the date of death from any cause, whichever came first, assessed up to 60 months

Rate of patients who will require surgery after 2, 4 and 6 study treatment cycles

Number and grade of adverse events related to the study treatments

Quality of Life evaluation related to received chemotherapy

Number of days spent in hospital related to treatment received

Italian Sarcoma Group

Lung cancer is one of the most common malignancies worldwide and the leading cause of cancer-related deaths in Western countries. Standard treatment for patients with good performance status (PS) stage IIIB/IV NSCLC currently includes a two-drug platinum-based chemotherapy regimen, but optimum treatment for elderly patients is less well-defined due to platinum related toxicities. Several drugs with novel mechanisms of action and significant activity in NSCLC have been developed; including docetaxel and gemcitabine that are also active in patients previously treated with cisplatin-based regimens and have a more favorable toxicity profile. The more favorable toxicity profile of docetaxel and gemcitabine supports its use as first-line chemotherapy, especially in patients with severe comorbidities as elderly patients. To improve the therapeutic index of this combination, the investigators performed a study with biweekly gemcitabine and docetaxel in elderly patients.

Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients

Phase II Study of Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non Small Cell Lung Cancer (NSCLC) Patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy	NCT00807261	Sarcoma	Gemcitabine and...	16 Years -	Asan Medical Center
Weekly Docetaxel and Fixed-Dose Rate Gemcitabine Combination Chemotherapy	NCT00807261	Sarcoma	Gemcitabine and...	16 Years -	Asan Medical Center
Biweekly Gemcitabine and Docetaxel as First Line Therapy for Advanced Non-Small Cell Lung Cancer (NSCLC) Patients	NCT00906061	Carcinoma, Non-...	Gemcitabine and...	18 Years -	Hospital Arnau de Vilanova
A Phase II Trial Comparing Gemcitabine and Pazopanib Versus Gemcitabine and Docetaxel for Patients With Advanced Soft Tissue Sarcoma	NCT01593748	Sarcoma	Gemcitabine and... Gemcitabine and...	18 Years -	Medical University of South Carolina
Phase II Trial for the Treatment of Relapsed Osteosarcoma	NCT02718482	OSTEOSARCOMA	Gemcitabine and... Ifosfamide	4 Years -	Italian Sarcoma Group
Biweekly Gemcitabine and Docetaxel as First Line Treatment for Advanced Disease in Elderly Non-Small Cell Lung Cancer (NSCLC) Patients	NCT00905983	Carcinoma, Non-...	Gemcitabine and...	70 Years -	Hospital Arnau de Vilanova

Spots Global Cancer Trial Database for gemcitabine and docetaxel