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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Carboplatin
Combretastatin
Fosbretabulin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014