NCT00113438

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2 cancer

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 8, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

Enrollment Period

1.9 years

First QC Date

June 7, 2005

Last Update Submit

October 28, 2011

Conditions

CancerTumor

Keywords

cancertumorimageableCA4PCombretastatinCombretastatin A4 PhosphateCombretastatin A-4 PhosphateCarboplatinPaclitaxelcarbotaxol

Outcome Measures

Primary Outcomes (4)

  • 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

  • To evaluate tumor response

    From baseline through end of study visit

  • 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

  • To assess the change in tumor blood flow by use of MRI in advanced imageable malignancies

    from screening through end of study visit

Study Arms (2)

45 mg/m2 Combretastatin A-4 Phosphate

EXPERIMENTAL
Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin

60 mg/m2 Combretastatin A-4 Phosphate

EXPERIMENTAL
Drug: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin

Interventions

Combretastatin A-4 Phosphate + Paclitaxel + CarboplatinDRUG

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.

Also known as: CA4P, fosbretabulin, paclitaxel, carboplatin
45 mg/m2 Combretastatin A-4 Phosphate60 mg/m2 Combretastatin A-4 Phosphate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Uncontrolled brain metastasis.
  • Significant cardiac abnormalities.
  • Prior radiotherapy at the tumor site.
  • Symptomatic peripheral vascular or cerebrovascular disease.
  • Uncontrolled hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

fosbretabulinPaclitaxelCarboplatin

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2005

First Posted

June 8, 2005

Study Start

March 1, 2005

Primary Completion

February 1, 2007

Study Completion

February 1, 2007

Last Updated

November 1, 2011

Record last verified: 2011-10

Locations

US(1)