Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors

Breast Cancer - Female Clinical Trial

Official title:

Phase I Study of Pazopanib in Combination With Weekly Paclitaxel and Carboplatin to Assess the Safety and Tolerability in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01407562
• Other study ID #: Pro0220110062
• Secondary ID: P30CA072720NCI-2
• Status: Terminated
• Phase: Phase 1
• Start date: September 17, 2010
• Est. completion date: March 29, 2016

Study information

• Verified date: September 2022
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open label, dose escalation study to determine the safety and tolerability and maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors.

Description:

This is an open label, dose escalation study to determine the maximum tolerated dose (MTD) of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors. There will be a dose expansion cohort of thirty patients to assess detailed pharmacokinetics and to assess any signal of activity in patients with solid tumors and in a portion who have breast cancer that is triple negative (ER-negative, PR-negative, and HER2-negative).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: March 29, 2016
• Est. primary completion date: March 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of a solid malignancy with advanced disease that has relapsed, that is refractory to standard therapies, or for which there is not standard therapy, or for which the patient opts not to receive standard therapy.

• At the recommended phase II dose level, triple-negative breast cancer defined as ER-negative, PR-negative, and HER2-negative, will be enrolled and another 10 patients with a solid malignancy who would benefit from a paclitaxel and carboplatin-based regimen, will also be enrolled.

• Male or female = 18 years of age

• Able to swallow and retain oral medications

Exclusion Criteria:

• Major surgery within last 28 days or cytotoxic chemotherapy, biologic therapy, investigational agents, or radiotherapy within last 21 days. Patients who have completed therapy with mitomycin C or nitrosurea will have to wait 42 days.

• More than 3 prior lines of cytotoxic chemotherapy for metastatic disease

Related Conditions & MeSH terms

• Breast Cancer - Female
• Neoplasms
• Unspecified Adult Solid Tumor - Protocol Specific

Intervention

Drug:
• Pazopanib
Starting dose is 400 given on Days 2-5, 9-12, and 16-26 of each 28 day cycle
• Paclitaxel
Starting dose is 60 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle
• Carboplatin
Starting dose of carboplatin that corresponds to an AUC of 2, IV on days 1, 8, and 15 of each 28 day cycle

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (4)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	GlaxoSmithKline, National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the maximum tolerated dose (MTD) of pazopanib with weekly paclitaxel and carboplatin on a 28- day cycle	Toxicity will be assessed every 28 days up to 30 days after the last dose of treatment. Dose limiting toxicity is defined as; Non-hematological toxicity = grade 3 (excluding alopecia, nausea, vomiting, or diarrhea for which adequate supportive therapy has not been instituted).; Hematologic toxicity: Grade 4 neutropenia lasting = 7 days; Grade 4 neutropenia and fever of = 38.5°C; = Grade 3 neutropenia with = Grade 3 infection; Grade 4 thrombocytopenia; Inability to start next cycle of treatment by more than 4 weeks due to unresolved toxicity	4 years, 6 months
Secondary	Determine the drug-drug interactions with paclitaxel, carboplatin, and pazopanib	The first 15 patients enrolled in the dose expansion cohort will undergo PK sampling as this is felt to be an adequate sample size.; 4 blood samples (2 mL each) for the analysis of paclitaxel will be obtained in Cycle 1 Day 1 and Cycle 2 Day 1; 2 blood samples (2 mL each) for the analysis of carboplatin will be obtained in Cycle 1 Day 1 and Cycle 2 Day 1; 1 blood sample (2 mL) for the analysis of pazopanib will be collected in Cycle 2 Day 1	4 years, 3 months