A Phase II Study of Interaction of Lovastatin and Paclitaxel For Patients With Refractory or Relapsed Ovarian Cancer

NCT00585052 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 200305074
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if the treatment combination of paclitaxel and lovastatin is more effective than the currently available chemotherapy for refractory or relapsed ovarian cancer. This research is being done to improve on currently available chemotherapy for ovarian cancer.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Epithelial Ovarian Cancer; Lovastatin; Paclitaxel

Outcome Measures

Primary Outcomes (1)

• Tumor Response Rate of the Combination of Lovastatin and Paclitaxel.

  Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>/= 20 mm with conventional techniques. The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow up. Image based evaluation is preferred to evaluation by clinical examination * Clinical Examination: Clinically detected lesions will only be considered measurable when they are superficial (e.g. skin nodules and palpable lymph nodes.) * Image based evaluation (CT and MRI): Conventional CT and MRI are currently the most reproducible methods of measuring lesions for response assessment.

  8 weeks

Secondary Outcomes (1)

• Time to Progression Using the Combination of Lovastatin and Paclitaxel.

  Up to one year

Study Arms (1)

Paclitaxel and lovastatin

EXPERIMENTAL

Paclitaxel given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly. Lovastatin self-administered at 80mg daily.

Drug: Paclitaxel; Drug: Lovastatin

Interventions

Paclitaxel DRUG

Paclitaxel will be given at 80 mg/m2 IV over 1 hour on day 1 and repeated weekly

Also known as: Abraxane, Taxol

Paclitaxel and lovastatin

Lovastatin DRUG

Lovastatin, 80 mg, po, daily will be self-administered by the subject.

Also known as: Mevacor, Altoprev

Paclitaxel and lovastatin

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with platinum refractory epithelial ovarian cancer: Defined as those patients with histologically confirmed epithelial ovarian cancer that have not responded (progressive or stable disease as a best response) to an initial chemotherapy regimen that included a platinum agent (cisplatin or carboplatin).
• Patients with platinum resistant ovarian cancer: Defined as those patients with histologically confirmed epithelial ovarian cancer that have relapsed less than 6 months after completion of prior platinum based chemotherapy. If the patient had responded but progressed more than 6 months after completing therapy, the patient must have received at least one additional course of platinum containing chemotherapy or recurred within 6 months of discontinuation of the second-line treatment program.
• Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded ) as \>/= 20 mm with conventional techniques. The same method of assessment and the same technique should be used to characterize each identified and reported lesion at baseline and during follow up. Image based evaluation is preferred to evaluation by clinical examination. Lesions that are considered to be unmeasurable include the following: bone lesions, leptomeningeal disease, ascites and pleural/pericardial disease.
• Prior treatment with any number of chemotherapeutic regimens is permitted as long as there was an interval of at least 4 weeks since the last chemotherapy.
• Prior treatment with paclitaxel chemotherapy is permitted as long as it was administered on a \>/= 3 week regimen and it has been at least 4 weeks since the last treatment.
• Normal Hepatic function
• Total Bilirubin \< 2 times upper limits of normal range.
• Transaminases \< 2 times upper limits of normal range
• Non-pregnant and non-nursing. Treatment under this protocol would expose an unborn child to significant risks. Women of reproductive potential should agree to use an effective means of birth control.

You may not qualify if:

• Other serious illnesses, which would limit survival to \<2 years, or a psychiatric condition, which would prevent compliance with treatment or informed consent.
• Performance Status \>2
• Uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, or infection, which in the opinion of the treating physician would make this protocol treatment unreasonably hazardous for the patient.
• Patients with a "currently active" second malignancy other than non-melanoma skin cancers. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse within one year.
• Patients who have received any investigational agent within the prior 4 weeks.
• Age \< 18 as there is no safety data for lovastatin in this age range.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

Holden Comprehensive Cancer Center

Iowa City, Iowa, 52327, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Paclitaxel; Albumin-Bound Paclitaxel; Lovastatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds

Limitations and Caveats

Trial closed early due to slow accrual, PI left the institution

Results Point of Contact

• Title: Raymond Hohl, MD
• Organization: University of Iowa

rhohl@pennstatehealth.psu.edu

319-335-6564

Study Officials

• Raymond Hohl, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: August 1, 2003
• Primary Completion: February 1, 2010
• Study Completion: June 1, 2013
• Last Updated: January 5, 2018
• Results First Posted: January 5, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)