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

A Phase II Evaluation of Epothilone-B BMS 247550 (NSC # 710428) in the Treatment of Recurrent or Persistent Platinum and Paclitaxel Refractory Ovarian or Primary Peritoneal Cancer

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00025155
Enrollment
51
Registered
2003-01-27
Start date
2002-07-31
Completion date
2010-03-31
Last updated
2019-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer

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.

Detailed description

PRIMARY OBJECTIVES: I. Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer. II. Determine the nature and degree of toxicity of this drug in these patients. OUTLINE: 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. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Interventions

DRUGixabepilone

Given IV

Sponsors

Gynecologic Oncology Group
CollaboratorNETWORK
National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* 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) * SGOT (serum glutamate oxaloacetate transaminase) ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN * Creatinine ≤ 1.5 times ULN * No sensory or motor neuropathy \> grade 1 * No dementia or altered mental status * No other serious uncontrolled medical disorder * No active infection requiring antibiotics * No prior hypersensitivity reaction to paclitaxel or other therapy containing Cremophor EL * No other malignancy within the past 5 years except nonmelanoma skin cancer * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * At least 3 weeks since prior biologic therapy * At least 3 weeks since prior immunotherapy * Must have received: * 1 prior combination taxane-based and platinum-based chemotherapy regimen * 1 prior platinum-based chemotherapy regimen AND 1 prior taxane-based chemotherapy regimen * Initial treatment may include high-dose therapy, consolidation, or extended therapy * At least 3 weeks since prior chemotherapy and recovered * No prior ixabepilone * No other prior cytotoxic chemotherapy for recurrent or persistent disease, including treatment with initial regimen * At least 1 week since prior hormonal anticancer therapy * Concurrent hormone replacement therapy allowed * At least 3 weeks since prior radiotherapy and recovered * No prior radiotherapy to site(s) of measurable disease * No radiotherapy to \> 25% of marrow-containing areas * Recovered from recent surgery * At least 3 weeks since other anticancer therapy * No prior anticancer therapy that precludes study participation * No concurrent food supplements (e.g., St. John's wort) * No concurrent amifostine or other protective agents

Design outcomes

Primary

MeasureTime frameDescription
Tumor ResponseEvery other cycle until the completion of study treatment with an average of study treatment time as of 3 months.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.
Number of People With Adverse EffectsEvery cycle until completion of study treatment up to 30 days after stopping study treatment

Secondary

MeasureTime frameDescription
Progression Free SurvivalFrom study entry to disease progression, death or date of last contact, whichever occurs first. Every other cycle, up to 5 years of follow-upProgression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.
Overall SurvivalFrom study entry to death or last contact, up to 5 years of follow-up.Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Countries

United States

Participant flow

Participants by arm

ArmCount
Treatment (Ixabepilone)
Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. 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.
49
Total49

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyIneligible: Second primary cancer site1
Overall StudyIneligible: Wrong primary cancer site1

Baseline characteristics

CharacteristicTreatment (Ixabepilone)
Age, Customized
20-29 years
1 participants
Age, Customized
30-39 years
0 participants
Age, Customized
40-49 years
6 participants
Age, Customized
50-59 years
13 participants
Age, Customized
60-69 years
15 participants
Age, Customized
70-79 years
13 participants
Age, Customized
80-89 years
1 participants
Histologic Type
Adenocarcinoma, unspecified
1 participants
Histologic Type
Clear Cell Carcinoma
4 participants
Histologic Type
Endometrioid Adenocarcinoma
2 participants
Histologic Type
Mixed Epithelial Carcinoma
3 participants
Histologic Type
Mucinous Adenocarcinoma
1 participants
Histologic Type
Serous Adenocarcinoma
38 participants
International Federation of Gynecology and Obstetrics (FIGO) Stage - Recurrent/Persistent49 participants
Region of Enrollment
United States
49 participants
Sex: Female, Male
Female
49 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
49 / 49
serious
Total, serious adverse events
16 / 49

Outcome results

Primary

Number of People With Adverse Effects

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

Population: Eligible and treated patients

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Treatment (Ixabepilone)Number of People With Adverse EffectsDermatologic23 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsFatigue11 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsMetabolic36 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsPain29 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsHematologic43 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsPulmonary37 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsLeukopenia13 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsThrombocytopenia39 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsInfection43 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsAllergy46 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsOcular48 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsNeutropenia17 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsGastrointestinal10 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsHemorrhage48 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsCardiovascular45 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsHepatic36 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsNeurologic20 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsEndocrine48 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsGenitourinary/Renal41 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsCoagulation47 Participants
Treatment (Ixabepilone)Number of People With Adverse EffectsAnemia9 Participants
Grade 1Number of People With Adverse EffectsPain10 Participants
Grade 1Number of People With Adverse EffectsGastrointestinal15 Participants
Grade 1Number of People With Adverse EffectsFatigue16 Participants
Grade 1Number of People With Adverse EffectsEndocrine1 Participants
Grade 1Number of People With Adverse EffectsDermatologic13 Participants
Grade 1Number of People With Adverse EffectsThrombocytopenia10 Participants
Grade 1Number of People With Adverse EffectsOcular0 Participants
Grade 1Number of People With Adverse EffectsNeutropenia10 Participants
Grade 1Number of People With Adverse EffectsMetabolic6 Participants
Grade 1Number of People With Adverse EffectsAnemia23 Participants
Grade 1Number of People With Adverse EffectsHepatic10 Participants
Grade 1Number of People With Adverse EffectsNeurologic12 Participants
Grade 1Number of People With Adverse EffectsHematologic0 Participants
Grade 1Number of People With Adverse EffectsInfection2 Participants
Grade 1Number of People With Adverse EffectsAllergy1 Participants
Grade 1Number of People With Adverse EffectsLeukopenia9 Participants
Grade 1Number of People With Adverse EffectsHemorrhage1 Participants
Grade 1Number of People With Adverse EffectsCardiovascular3 Participants
Grade 1Number of People With Adverse EffectsPulmonary1 Participants
Grade 1Number of People With Adverse EffectsGenitourinary/Renal6 Participants
Grade 1Number of People With Adverse EffectsCoagulation0 Participants
Grade 2Number of People With Adverse EffectsInfection2 Participants
Grade 2Number of People With Adverse EffectsLeukopenia20 Participants
Grade 2Number of People With Adverse EffectsThrombocytopenia0 Participants
Grade 2Number of People With Adverse EffectsNeutropenia12 Participants
Grade 2Number of People With Adverse EffectsAnemia13 Participants
Grade 2Number of People With Adverse EffectsHematologic3 Participants
Grade 2Number of People With Adverse EffectsAllergy2 Participants
Grade 2Number of People With Adverse EffectsCardiovascular0 Participants
Grade 2Number of People With Adverse EffectsHemorrhage0 Participants
Grade 2Number of People With Adverse EffectsCoagulation0 Participants
Grade 2Number of People With Adverse EffectsFatigue15 Participants
Grade 2Number of People With Adverse EffectsDermatologic13 Participants
Grade 2Number of People With Adverse EffectsEndocrine0 Participants
Grade 2Number of People With Adverse EffectsGastrointestinal14 Participants
Grade 2Number of People With Adverse EffectsGenitourinary/Renal1 Participants
Grade 2Number of People With Adverse EffectsHepatic2 Participants
Grade 2Number of People With Adverse EffectsMetabolic3 Participants
Grade 2Number of People With Adverse EffectsNeurologic14 Participants
Grade 2Number of People With Adverse EffectsOcular1 Participants
Grade 2Number of People With Adverse EffectsPain8 Participants
Grade 2Number of People With Adverse EffectsPulmonary9 Participants
Grade 3Number of People With Adverse EffectsCoagulation2 Participants
Grade 3Number of People With Adverse EffectsGastrointestinal9 Participants
Grade 3Number of People With Adverse EffectsCardiovascular1 Participants
Grade 3Number of People With Adverse EffectsPain1 Participants
Grade 3Number of People With Adverse EffectsGenitourinary/Renal1 Participants
Grade 3Number of People With Adverse EffectsAllergy0 Participants
Grade 3Number of People With Adverse EffectsHepatic1 Participants
Grade 3Number of People With Adverse EffectsHematologic3 Participants
Grade 3Number of People With Adverse EffectsInfection2 Participants
Grade 3Number of People With Adverse EffectsAnemia4 Participants
Grade 3Number of People With Adverse EffectsMetabolic4 Participants
Grade 3Number of People With Adverse EffectsNeutropenia9 Participants
Grade 3Number of People With Adverse EffectsHemorrhage0 Participants
Grade 3Number of People With Adverse EffectsNeurologic3 Participants
Grade 3Number of People With Adverse EffectsThrombocytopenia0 Participants
Grade 3Number of People With Adverse EffectsOcular0 Participants
Grade 3Number of People With Adverse EffectsDermatologic0 Participants
Grade 3Number of People With Adverse EffectsFatigue6 Participants
Grade 3Number of People With Adverse EffectsLeukopenia6 Participants
Grade 3Number of People With Adverse EffectsEndocrine0 Participants
Grade 3Number of People With Adverse EffectsPulmonary2 Participants
Grade 4Number of People With Adverse EffectsOcular0 Participants
Grade 4Number of People With Adverse EffectsMetabolic0 Participants
Grade 4Number of People With Adverse EffectsGastrointestinal1 Participants
Grade 4Number of People With Adverse EffectsCardiovascular0 Participants
Grade 4Number of People With Adverse EffectsLeukopenia1 Participants
Grade 4Number of People With Adverse EffectsEndocrine0 Participants
Grade 4Number of People With Adverse EffectsDermatologic0 Participants
Grade 4Number of People With Adverse EffectsGenitourinary/Renal0 Participants
Grade 4Number of People With Adverse EffectsAllergy0 Participants
Grade 4Number of People With Adverse EffectsNeurologic0 Participants
Grade 4Number of People With Adverse EffectsPain1 Participants
Grade 4Number of People With Adverse EffectsThrombocytopenia0 Participants
Grade 4Number of People With Adverse EffectsHepatic0 Participants
Grade 4Number of People With Adverse EffectsHematologic0 Participants
Grade 4Number of People With Adverse EffectsFatigue1 Participants
Grade 4Number of People With Adverse EffectsAnemia0 Participants
Grade 4Number of People With Adverse EffectsPulmonary0 Participants
Grade 4Number of People With Adverse EffectsInfection0 Participants
Grade 4Number of People With Adverse EffectsCoagulation0 Participants
Grade 4Number of People With Adverse EffectsNeutropenia1 Participants
Grade 4Number of People With Adverse EffectsHemorrhage0 Participants
Primary

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.

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

Population: Eligible and treated participants.

ArmMeasureValue (NUMBER)
Treatment (Ixabepilone)Tumor Response14.3 percentage of participants
Secondary

Overall Survival

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

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

Population: Eligible and treated participants.

ArmMeasureValue (MEDIAN)
Treatment (Ixabepilone)Overall Survival14.8 Months
Secondary

Progression Free Survival

Progression-Free Survival is the period from study entry until disease progression, death or date of last contact, whichever occurs first. Progression is defined as at least a 20% increase in the sum of the longest dimensions (LD) of target lesions taking as reference the smallest sum LD recorded since study entry, or a 50% increase in the LD taking as reference the smallest LD recorded since study entry in the case where the ONLY target lesion is a solitary pelvic mass measured by physical exam, or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions, or global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or death due to disease without prior objective documentation of progression.

Time frame: 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

Population: Eligible and treated participants.

ArmMeasureValue (MEDIAN)
Treatment (Ixabepilone)Progression Free Survival4.4 Months

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026