Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

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

Gemcitabine

Capecitabine

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Antimetabolites

Combination of gemcitabine, capecitabine, and bevacizumab

gemcitabine 1000 mg/m\^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle

gemcitabine 1000 mg/m\^2 d1, 8, capecitabine 1000 mg (flat dose) po bid d1-14, and bevacizumab 15 mg/kg d 1, on a 21 day cycle

combination of gemcitabine, capecitabine, and bevacizumab

Walter Stadler, MD

The purpose of this study is to find out what effects (good and bad) the combination of the chemotherapy drugs gemcitabine, capecitabine, and bevacizumab has on a patient and kidney cancer.

* to determine the objective response rate and estimate the time to progression of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic clear cell renal cell cancer;
* to determine survival of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic cell renal cell cancer;
* to determine the toxicity of combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic renal cell cancer;
* to collect baseline serum and plasma samples for exploration of possible prognostic and predictive markers

A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma

Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR.

Progression is defined as a measurable increase in the sum of longest diameters of all target lesions, or unequivocable progression of non-target lesions, or the appearance of new lesions, since baseline

Time from enrollment until death from any cause.

Genentech, Inc.

Eli Lilly and Company

University of Chicago

Reported are numbers of patients with grade 3 or higher toxicity National Cancer Institute Common Toxicity Criteria (version 3.0) were used to assess and report adverse events

Combination of Gemcitabine, Capecitabine, and Bevacizumab

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

ECOG performance status Scores on a scale Range 0-5, higher is worse

Performance Status

3 or more

Number of metastatic disease sites

Clear cell

Poorly differentiated/unclassified

Tumor histology

Unknown

An important factor used to assess renal cell carcinoma is its Fuhrman grade. This scale refers to how closely the cancer cells look like normal kidney cells under a microscope. The Fuhrman grading system ranks tumor cells on a scale of 1 through 4 and is a prognostic scale. 1 represents the best prognosis and 4 the worst. Grade 1 tumor cells look similar to normal kidney cells. Grade 1 cancers typically grow and spread slowly and most often have a good prognosis. Grade 4 tumor cells look quite different from normal kidney cells and have a worse prognosis.

Fuhrman grade

Favorable

Intermediate

Poor

Prognostic risk group

Prior therapy-Nephrectomy

Prior therapy-Radiotherapy

Prior therapy-Cytokine therapy

Prior therapy-Oral Vascular Endothelial Growth Factor (VEGF) receptor kinase inhibitor

Trial was designed with a maximum target accrual of 55 patients. The trial was halted early because emerging data with VEGF inhibitors challenged clinical relevance of the study and availability of multiple therapies challenged accrual.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma	NCT00523640	Carcinoma, Rena...	combination of ...	18 Years -	University of Chicago
A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma	NCT00523640	Carcinoma, Rena...	combination of ...	18 Years -	University of Chicago
A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma	NCT00523640	Carcinoma, Rena...	combination of ...	18 Years -	University of Chicago

Spots Global Cancer Trial Database for combination of gemcitabine, capecitabine, and bevacizumab