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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

OXiGENE

ClinicalTrials.gov Identifier:

NCT00113438

First received: June 7, 2005

Last updated: October 28, 2011

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	June 7, 2005
Last Updated Date	October 28, 2011
Start Date ^ICMJE	March 2005
Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 22, 2011)	To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies [ Time Frame: From first administration of study drug through approximately 30 days following last dose of study drug ] [ Designated as safety issue: Yes ] To evaluate tumor response [ Time Frame: From baseline through end of study visit ] [ Designated as safety issue: No ] To establish the Recommended Phase II Dose (RP3D) for the combination of CA4P-paclitaxel-carboplatin in advanced imageable malignancies [ Time Frame: from first study drug administration through end of study visit ] [ Designated as safety issue: Yes ] To assess the change in tumor blood flow by use of MRI in advanced imageable malignancies [ Time Frame: from screening through end of study visit ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	To assess safety and toxicity of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies To establish the Recommended Phase II Dose (RP3D) for the combination of CA4P-paclitaxel-carboplatin in advanced imageable malignancies To assess the change in tumor blood flow by use of MRI in advanced imageable malignancies To gather preliminary data on the anti-tumor efficacy of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies
Change History	Complete list of historical versions of study NCT00113438 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of Combretastatin A-4 Phosphate Combined With Chemotherapy in Advanced Solid Tumors
Official Title ^ICMJE	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
Brief 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.
Detailed 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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Cancer Tumor
Intervention ^ICMJE	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. Other Names: CA4P fosbretabulin paclitaxel carboplatin
Study Arm (s)	Experimental: 45 mg/m2 Combretastatin A-4 Phosphate Intervention: Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin Experimental: 60 mg/m2 Combretastatin A-4 Phosphate Intervention: Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	13
Completion Date	February 2007
Primary Completion Date	February 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00113438
Other Study ID Numbers ^ICMJE	CA4P-212, HCI-13214
Has Data Monitoring Committee	No
Responsible Party	OXiGENE
Study Sponsor ^ICMJE	OXiGENE
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	OXiGENE
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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