Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy

NCT00025155 | Completed Phase 2 Results

• 4 other identifiers: NCI-2012-02413CDR0000068927GOG-0126MU10CA027469
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die.

Conditions

Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (2)

• Tumor Response

  Percentage of participants with complete and partial tumor response as assessed by the Gynecologic Oncology Group Response Evaluation Criteria in Solid Tumors (GOG RECIST) with one-sided 90% Confidence Interval. Complete Response (CR), disappearance of all target and non-target lesions without evidence of new lesion; Partial Response (PR), \>=30% decrease in the sum of the longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD with no unequivocal progression of non-target lesions and no evidence of new lesion, or a 50% decrease in the LD in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam with no unequivocal progression of non-target lesions and no evidence of new lesion. Complete or partial response requires confirmation at greater than or equal to 4 weeks from initial documentation.

  Every other cycle until the completion of study treatment with an average of study treatment time as of 3 months.

• Number of People With Adverse Effects

  Every cycle until completion of study treatment up to 30 days after stopping study treatment

Secondary Outcomes (2)

• Progression Free Survival

  From study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-up

• Overall Survival

  From study entry to death or last contact, up to 5 years of follow-up.

Study Arms (1)

Treatment (ixabepilone)

EXPERIMENTAL

Patients receive ixabepilone IV over 1 hour. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.

Drug: ixabepilone

Interventions

ixabepilone DRUG

Given IV

Also known as: BMS-247550, epothilone B lactam, Ixempra

Treatment (ixabepilone)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed ovarian epithelial cancer or primary peritoneal cancer
• Recurrent or persistent disease
• Platinum AND taxane-resistant or refractory disease
• Progressed during therapy
• Refractory disease within 6 months of therapy
• Measurable disease
• At least 20 mm by conventional techniques
• At least 10 mm by spiral CT scan
• Tumor lesions located within a previously irradiated field are not considered measurable disease unless there is documented tumor progression in these lesions or biopsy confirmation ≥ 90 days following completion of radiotherapy
• Ineligible for higher priority GOG (Gynecologic Oncology Group) protocol
• No active brain metastases
• Performance status - GOG 0-2
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• Gynecologic Oncology Group: collaborator

Study Sites (1)

Gynecologic Oncology Group

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

ixabepilone

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; 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

Results Point of Contact

• Title: Angela M. Kuras, Associate Director of Data Management
• Organization: NRG Oncology Statistics and Data Management Center - Buffalo

kurasa@nrgoncology.org

716-845-7733

Study Officials

• David R. Spriggs

  Gynecologic Oncology Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2001
• First Posted: January 27, 2003
• Study Start: July 1, 2002
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: July 24, 2019
• Results First Posted: July 13, 2015

Record last verified: 2019-07

Locations

US (1)