Neoplasms

All Conditions

Rare Diseases

Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Pazopanib will be started at a dose of 200 mg BID for four days, then escalated to a dose of 400 mg BID for four days, then escalated once more to a dose of 800 mg QD for the duration of participation (or until dose reduction, if necessary). Pazopanib should be taken orally without food at least one hour before or two hours after a meal. One cycle of pazopanib is 28 days.

Pazopanib

Brian A Van Tine, M.D., Ph.D.

Pazopanib is FDA approved as a second line and beyond treatment for metastatic soft tissue sarcoma. There is a population of elderly and debilitated soft tissue sarcoma patients that are not fit for standard first line chemotherapy that is doxorubicin based. As pazopanib is well tolerated with minimal side effects, the investigators propose a phase II study to evaluate pazopanib as a first-line agent in patients with non-resectable or metastatic disease who are not candidates for cytotoxic chemotherapy.

Pazopanib as Front-Line Therapy in Patients With Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy

A Phase II Study of Pazopanib as Front-Line Therapy in Patients With Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy

Clinical benefit rate = complete response (CR) + partial response (PR) + stable disease (SD)

* CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.
* PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
* 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.

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

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. (Note: the appearance of one or more new lesions is also considered progressions).

* Quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G7) validated survey
* 7 statements where the participant can indicate 0 (not at all) up to 4 (very much). The statements include 1) I have lack of energy; 2) I have pain; 3) I have nausea; 4) I worry that my condition will get worse; 5) I am sleeping well; 6) I am able to enjoy life; 7) I am content with the quality of my life right now.
* The first 4 statements will negatively affect the total score and the last 3 statements will positively affect the total score
* Each item is scored and then added together, multiplied by 7, and divided by the number of items
* Total score calculation ranges from 0-28. The higher the score, the better the quality of life

The serum levels of sVEGFR2 at each time point will plotted and Pearson or Spearman's correlation coefficient will be calculated to explore their relationship.

The serum levels of PIGF at each time point will plotted and Pearson or Spearman's correlation coefficient will be calculated to explore their relationship.

Novartis Pharmaceuticals

Washington University School of Medicine

The adverse events listed in the other (not including serious) adverse event module are deemed to be related to treatment.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Brian A. Van Tine, M.D., Ph.D.

Clinical Benefit Rate

Progression-free Survival (PFS)

Overall Survival (OS)

Median Overall Change in Quality of Life

There was no funding to process the serum levels of sVEGFR2.

Clinical Outcome Associated With Serum sVEGFR2 Levels (Serum Levels of sVEGFR2 at Each Time Point Will Plotted and Pearson or Spearman's Correlation Coefficient)

There was no funding to process the serum levels of PIGF.

Clinical Outcome Associated With Serum PICG Levels (Serum Levels of PIGF at Each Time Point Will Plotted and Pearson or Spearman's Correlation Coefficient)

Spots Global Cancer Trial Database for Pazopanib as Front-Line Therapy in Patients With Non-Resectable or Metastatic Soft Tissue Sarcomas Who Are Not Candidates for Chemotherapy

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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