Brief Title
Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
A Phase I/II Trial of Weekly Paclitaxel In Combination With Ganetespib In Patients With Recurrent, Platinum-Resistant Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Brief Summary
This phase I/II trial studies the side effects and best dose of ganetespib when given
together with paclitaxel and to see how well they work in treating patients with recurrent
ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as
paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Ganetespib may stop the growth of tumor cells by
blocking some of the enzymes needed for cell growth. Giving paclitaxel and ganetespib may be
an effective treatment for ovarian, fallopian tube, or primary peritoneal cancer.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the recommended Phase II dose of ganetespib with weekly paclitaxel. (Phase I)
II. Probability of surviving progression-free for at least 6 months after initiating therapy.
(Phase II) III. Clinical response rate (partial and complete responses as defined by Response
Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria). (Phase II)
SECONDARY OBJECTIVES:
I. Determine the nature and degree of toxicity of ganetespib and weekly paclitaxel in this
cohort of patients as measured by the frequency and severity of adverse reactions. (Phase I)
II. Determine the nature and degree of toxicity of ganetespib and weekly paclitaxel in this
cohort of patients as measured by the frequency and severity of adverse reactions
encountered. (Phase II) III. Duration of progression-free survival. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of ganetespib followed by a phase II study.
Patients receive paclitaxel intravenously (IV) over 1 hour and ganetespib IV over 1 hour on
days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 2 years, and then annually thereafter.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Recommended Phase II Dose of Ganetespib With Weekly Paclitaxel, Based on the Incidence of Dose-limiting Toxicity (DLT) Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 (Phase I)
Secondary Outcome
Duration of Progression-free Survival (Phase II)
Condition
Recurrent Fallopian Tube Cancer
Intervention
paclitaxel
Study Arms / Comparison Groups
Phase 1: 100 mg/m2 ganetespib, 80 mg/m2 paclitaxel
Description: Patients receive paclitaxel IV over 1 hour and ganetespib IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Ganetespib escalation will follow a modified 3+3 design and escalate from 100mg/m2 to 125mg/m2 to 150mg/m2.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
12
Start Date
October 9, 2013
Completion Date
July 6, 2018
Primary Completion Date
May 9, 2016
Eligibility Criteria
Inclusion Criteria:
- Patients with histologically or cytologically confirmed recurrent epithelial ovarian,
fallopian tube or primary peritoneal cancers who have received up to two prior
treatment regimens
- Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension in accordance with RECIST criteria
version (v.) 1.1
- Patients must have had one prior platinum-based chemotherapeutic regimen for
management of primary disease containing carboplatin, cisplatin, or another
organoplatinum compound; this initial treatment may have included intraperitoneal
therapy, high-dose therapy, consolidation, or extended therapy administered after
completion of initial chemotherapy; patients must be considered platinum resistant or
refractory according to standard Gynecologic Oncology Group (GOG) criteria, i.e., have
had a treatment-free interval following platinum of less than 12 months, have
persistent disease at the completion of primary platinum-based therapy or have
progressed during platinum-based therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin =< normal institutional limits
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) (serum glutamic
oxaloacetic transaminase [SGOT]/serum glutamate pyruvate transaminase [SGPT]) =< 2
times institutional normal limits
- Creatinine =< normal institutional limits OR
- Creatinine clearance >= 60 Ml/min/1.73 m^2 for patients with creatinine levels above
institutional normal
- Ability and willingness to comply with scheduled visits, treatment plan, laboratory
assessments and other study procedures
- Ability to understand and willingness to sign a written informed consent and Health
Insurance Portability and Accountability Act (HIPAA) consent document
Exclusion Criteria:
- Patients who have had surgery, chemotherapy or radiotherapy within 4 weeks prior to
entering the study or those who have toxicity that has not recovered to =< grade 1
from adverse events due to agents administered more than 4 weeks earlier (with the
exception of alopecia); patients may not be receiving any other investigational agents
- Histologic diagnosis of a benign or borderline tumor ('tumor of low malignant
potential') or of a malignant tumor of non-epithelial origin (such as a germ cell
tumor, sex-cord stromal tumor) of the ovary, fallopian tube or peritoneum
- Patients with known brain metastases
- History of allergic reactions to Cremophor EL, paclitaxel or its components
- Prior history of >= grade 2 neurotoxicity or any other toxicity requiring
discontinuation of taxane therapy that has not resolved to =< grade 1, with the
exception of alopecia
- Diagnosis of another malignancy within two years before the first dose, or previously
treated for another malignancy with evidence of residual disease, with the exception
of a synchronous endometrial cancer; carcinoma in situ will not be considered as
malignancy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, known serious cardiac illness or psychiatric illness/social situations that
would limit compliance with study requirements; known serious cardiac illness or
medical conditions include, but are not limited to:
- History of documented congestive heart failure (CHF), New York Heart Association
(NYHA) class II/III/IV, with a history of dyspnea, orthopnea, or edema that
requires current treatment with angiotensin-converting enzyme (ACE) inhibitors,
angiotensin II receptor blockers, beta blockers, or diuretics
- NOTE: use of these medications for the treatment of hypertension is allowed
- Screening QTc (QT interval corrected for heart rate) > 470 msec or history of QT
(cardiac interval from start of Q wave to end of T wave) prolongation while
taking other medications
- High-risk uncontrolled arrhythmias (ventricular arrhythmias, high-grade
atrioventricular [AV]-block, supra-ventricular arrhythmias that are not
adequately rate-controlled)
- Arrhythmias that require current treatment with the following anti-arrhythmic
drugs: flecainide, moricizine, or propafenone
- Current coronary artery disease with a history of myocardial infarction,
angioplasty, or coronary bypass surgery within the preceding 6 months, or angina
pectoris that has been symptomatic within the preceding 6 months
- Known human immunodeficiency virus (HIV)-positive patients on combination
antiretroviral therapy are ineligible
- Pregnant or breast feeding
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gina Martina-Smaldone, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01962948
Organization ID
GYN-064
Secondary IDs
NCI-2013-01416
Responsible Party
Sponsor
Study Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Gina Martina-Smaldone, MD, Principal Investigator, Fox Chase Cancer Center
Verification Date
September 2022