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
  Purpose

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.


Condition Intervention Phase
Cancer
Tumor
Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by OXiGENE:

Primary Outcome Measures:
  • 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 ]

Enrollment: 13
Study Start Date: March 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 45 mg/m2 Combretastatin A-4 Phosphate 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
Experimental: 60 mg/m2 Combretastatin A-4 Phosphate 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113438

Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
OXiGENE
  More Information

No publications provided

Responsible Party: OXiGENE
ClinicalTrials.gov Identifier: NCT00113438     History of Changes
Other Study ID Numbers: CA4P-212, HCI-13214
Study First Received: June 7, 2005
Last Updated: October 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by OXiGENE:
cancer
tumor
imageable
CA4P
Combretastatin
Combretastatin A4 Phosphate
Combretastatin A-4 Phosphate
Carboplatin
Paclitaxel
carbo
taxol

Additional relevant MeSH terms:
Combretastatin
Paclitaxel
Combretastatin A-4
Carboplatin
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014