Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors

Cancer Clinical Trial

Official title:

A Randomized Open-Labeled Phase II Study of Combretastatin A-4 Phosphate in Combination With Paclitaxel and Carboplatin to Evaluate the Safety and Efficacy in Subjects With Advanced Imageable Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00113438
• Other study ID #: CA4P-212
• Secondary ID: HCI-13214
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2005
• Last updated: October 28, 2011
• Start date: March 2005
• Est. completion date: February 2007

Study information

• Verified date: October 2011
• Source: OXiGENE
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a study evaluating the safety and effectiveness of Combretastatin A4 Phosphate (CA4P) combined with the chemotherapy drugs, carboplatin and paclitaxel. The full treatment and observation time should be about 5 months. During this time the patient should receive 18 CA4P infusions and 6 carboplatin followed by paclitaxel treatments. Patients will be randomized into one of two CA4P dose-level groups in order to recommend a preferred dose-level for future studies. At least 2 dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) scans will be conducted to monitor the blood flow through the tumor before and after treatment with CA4P.

Description:

This is a phase II study evaluating the safety and efficacy of Combretastatin A4 Phosphate (CA4P) combined with carboplatin and paclitaxel. Treatment is for a maximum of 6 consecutive 21-day cycles. Patients are randomized onto one of two CA4P dosing arms (45 or 63 mg/m2). CA4P is administered on days 1, 8 and 15 of each cycle. Carboplatin and paclitaxel (AUC 6 and 200 mg/m2, respectively) are administered on day 2 of each cycle. At least 2 DCE-MRI scans will be performed to evaluate the change in tumor blood flow following treatment with CA4P.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Advanced malignancy where treatment with carboplatin and paclitaxel is warranted.

• Minimum 28-day interval from any surgical, chemotherapy or immunotherapy treatment and a 14-day interval from radiotherapy treatment.

• Radiologically measurable disease to meet MRI perfusion criteria.

• ECOG performance status less than or equal to 1.

• Life expectancy greater than 12 weeks.

• Normal ejection fraction.

Exclusion Criteria:

• Uncontrolled brain metastasis.

• Significant cardiac abnormalities.

• Prior radiotherapy at the tumor site.

• Symptomatic peripheral vascular or cerebrovascular disease.

• Uncontrolled hypertension.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Tumor

Intervention

Drug:
• Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin
Combretastatin A-4 Phosphate is administered IV at 45 mg/m2 or 60 mg/m2 on Days 1, 8 and 15 followed by paclitaxel (3 hour infusion at 200 mg/m2) and carboplatin (1 hour infusion at AUC = 6) on Day 2 of each cycle. The treatment cycle is 21 days with a maximum of 21 days. Following cycle 6, subjects that have not progressed may continue on CA4P monotherapy, which will be administered at 45 mg/m2 or 60 mg/m2 on Days 1 and 8 with rest on Day 15, repeated every 21 days until disease progression.

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
OXiGENE

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies		From first administration of study drug through approximately 30 days following last dose of study drug	Yes
Primary	To evaluate tumor response		From baseline through end of study visit	No
Primary	To establish the Recommended Phase II Dose (RP3D) for the combination of CA4P-paclitaxel-carboplatin in advanced imageable malignancies		from first study drug administration through end of study visit	Yes
Primary	To assess the change in tumor blood flow by use of MRI in advanced imageable malignancies		from screening through end of study visit	No