Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Sunitinib 37.5 mg/day; regimen 4/6 (Marketing Authorisation Indication) 4 weeks "on " alternating with 2 weeks "off "

Sunitinib 50 mg/day; regimen 2/3 (experimental arm) 2 weeks "on " alternating with 1 week "off "

antoine thiery-vuillemin, MD PhD

Patients who are candidates for first line treatment with Sunitinib 50mg 4/6 regimen in accordance with the Marketing Authorisation who meet the inclusion/exclusion criteria will be offered participation in this study during the consultation as part of their usual care. The patients will be included before Sunitinib treatment is started. Thereafter, sunitinib is initiated 50 mg/day; regimen 4/6 (Marketing Authorisation Indication), 4 weeks "on " alternating with 2 weeks "off "

As soon as a dose or schedule adjustment is required, regardless of cause, the patient will be randomised 1/1:

* Either into arm A and will receive 37.5mg of Sunitinib per day by the 4/6 regimen (in accordance with the Marketing Authorisation); 4 weeks "on " alternating with 2 weeks "off "
* Or into arm B and will receive 50mg of Sunitinib per day by the 2/3 regimen (investigational arm); 2 weeks "on " alternating with 1 week "off "

Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma

Open Label, Randomised Multi-centre Phase II Study to Assess the Efficacy and Tolerability of Sunitinib by Dose Administration Regimen (Dose Modification or Dose Interruptions) in Patients With Advanced or Metastatic Renal Cell Carcinoma

The primary objective of this study is to estimate the median duration of treatment in each treatment group (arm A vs arm B) calculated from sunitinib initiation.

To estimate progression-free survival in patients included in each of the groups and in the overall population included in this study.

To estimate overall survival in patients included in each of the groups and in the overall population included in this study.

Estimation of the time between date of randomization and sunitinib arrest (for any reason) in the two treatment arms.

To estimate the time to randomization defined as the time between the date of sunitinib initiation and the date of randomization.

To measure the objective response rate according to RECIST 1.1 criteria.

To assess safety profile before and after randomization.

To assess health-related quality of life since sunitinib is started (before randomization, at the time of randomization and after randomization)

Pfizer

Centre Hospitalier Universitaire de Besancon

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Capecitabine

Antimetabolites

Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

Miguel Martin, MD,PhD

Capecitabine is active in metastatic breast cancer but the conventional schedule (1250 mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in up to 50% of patients leading to those reductions. There are theoretical reasons to administer S-phase specific agents in continuous, protracted rather than intermittent schedules. The investigators study compares the standard schedule (1250 mg/m2/12 hr 2 weeks on, one week off) with a continuous administration schedule (800 mg/m2/12hr). The latter administer approximately the same cumulative dose of capecitabine as the standard schedule. The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from 50% (standard arm) to 20% (experimental arm). The investigators assume similar antitumor activity in both arms.

Capecitabine is active in metastatic breast cancer but the conventional schedule (1250 mg/m2/12 hr 2 weeks on, one week off) produces grade 2 or greater hand and foot syndrome in up to 50% of patients leading to those reductions. Some authors have tested continuous administration schedules of capecitabine, showing better tolerance and apparently similar antitumor activity. Capecitabine is a pro-drug of 5-FU and mimics an i.v. continuous infusion administration of this antimetabolite. On the other hand, there are theoretical reasons to administer S-phase specific agents in continuous, protracted rather than intermittent schedules. Our study compares the standard schedule(1250 mg/m2/12 hr 2 weeks on, one week off)with a continuous administration schule (800 mg/m2/12hr). The latter schedule administer approximately the same cumulative dose of capecitabine as the standard one. The study hypothesis is that grade 2 or greater hand and foot syndrome will be reduced from 50% (standard arm) to 20% (experimental arm). The investigators assume similar antitumor activity in both arms.

Standard Versus Continuous Capecitabine in Advanced Breast Cancer

Randomized Phase II Trial of Continuous Versus Standard Capecitabine in Advanced Breast Cancer.

Time to Progression (TTP) is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies due to progressive disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).

Response was evaluated using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), every 3 cycles of chemotherapy (each cycle lasts 3 weeks) and at the end of treatment (at 21 weeks from the start of treatment).

Response duration is computed for all patients with Partial Response or Complete Response, during the treatment period, as the time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first.

A patient is censored if she does not progress or die. In these cases Response duration is computed as the time from the moment the Partial or Complete Response is reported to the last contact date.

Time to treatment failure (TTF) is defined as the time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria.

If a patient did not end the treatment, it is censored. The censoring date is the date of the last dose received.

An event is defined as death. A patient is censored if she does not die. The censoring date is last contact date.

A patient experiences a Clinical Benefit if the following is satisfied:

Criterion: The patient has "Complete response", "Partial Response" or "Stable Disease" and it continues during more than 3 months.

Progression Free Survival is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies for any reason.

Complexo Hospitalario Universitario de A Coruña

Hospital San Carlos, Madrid

Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

A Cint

Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

B Ccont

Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

Arm A (Cint)

Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.

Arm B (Ccont)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Spain

Region of Enrollment

The Oncologist 2015;20:1-2 http://www.theoncologist.com/ Scientific Director and CEO

Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.

Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.

A total of 192 patients (95 in Arm A and 97 in Arm B) were considered for this analysis but 36 were censored (23 in Arm A and 13 in Arm B). Patients censored are those that did not progress or die due to progressive disease during the study treatment.

Time to Progression

There were 95 patients in Arm A and 97 patients in Arm B. There were 13 patients without response evaluation (9 in Arm A and 4 in Arm B).

Response Rate

From 192 patients (95 in Arm A and 97 in Arm B), 61 patients had Complete Response or Partial Response (30 in Arm A and 31 in Arm B).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Assess Various Sunitinib Schedules in Renal Cell Carcinoma	NCT02689167	Kidney Neoplasm... Metastatic Rena...	Sunitinib	18 Years -	Centre Hospitalier Universitaire de Besancon
Standard Versus Continuous Capecitabine in Advanced Breast Cancer	NCT00418028	Metastatic Brea...	Capecitabine	18 Years - 75 Years	Hospital San Carlos, Madrid
Standard Versus Continuous Capecitabine in Advanced Breast Cancer	NCT00418028	Metastatic Brea...	Capecitabine	18 Years - 75 Years	Hospital San Carlos, Madrid

Spots Global Cancer Trial Database for schedule

Every month we try and update this database with for schedule cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for schedule

Every month we try and update this database with for schedule cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for schedule cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.