A Phase 2 interventional study of temsirolimus in Fallopian Tube Cancer, Primary Peritoneal Cavity Cancer and Recurrent Ovarian Epithelial Cancer, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment
This phase II trial is studying the side effects and how well temsirolimus works in treating patients with refractory or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
OBJECTIVES: Primary I. Determine the 6-month progression-free survival (PFS) or objective tumor response in patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with temsirolimus.
II. Determine the toxicity of this drug in these patients.
Secondary I. Determine the duration of PFS and overall survival of these patients.
OUTLINE: This is a nonrandomized, multicenter study.
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study.
720 studies on the registry are indexed under Fallopian Tube Neoplasms; 127 are open to participants now.
This study's enrollment of 60 is above the median of 52 across 589 interventional studies indexed under Fallopian Tube Neoplasms.
Browse Fallopian Tube Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Histologically confirmed ovarian epithelial, fallopian tube or primary peritoneal cavity cancer
Prior treatment with ≥ 1 platinum-based chemotherapeutic regimen for management of primary disease (containing carboplatin, cisplatin, or another organoplatinum compound) required
Initial treatment may have included any of the following:
Patients must meet ≥ 1 of the following criteria:
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
Must have ≥ 1 target lesion
At least 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin
At least 3 years since prior adjuvant chemotherapy for localized breast cancer
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: temsirolimus
Given IV
Also known as: CCI-779, cell cycle inhibitor 779, Torisel
6 Month Progression-free Survival (PFS)
Number of participants who survived progression-free for more than 6 months.
Time frame: 6 months
Objective Tumor Response Based on the Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions.
Time frame: Up to 5 years
Frequency and Severity of Adverse Events as Assessed by the Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE v3.0)
Time frame: Up to 5 years
Duration of Progression-free Survival
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
Time frame: CT scan or MRI if used to follow lesion for measurable disease every other cycle for the first 6 months up to 5 years
Duration of 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: Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.
Reason Off Study Therapy
Time frame: from study entry until end of study treatment
Patient Vital Status
Patients alive or dead after 24 months from time of study entry
Time frame: Study entry up to 2 years
Patients were accrued to the first stage of accrual from 2/5/07 to 9/4/07. Patients were accrued to the second stage of accrual between 5/7/08 to 8/25/08. They received 25 mg IV of CCI-779 weekly. One cycle was 28 days.
| Milestone | Treatment (Temsirolimus) |
|---|---|
| Started | 60 |
| Completed | 54 |
| Not completed | 6 |
| Withdrew: Improper pre-protocol treatment | 3 |
| Withdrew: Required test not done | 1 |
| Withdrew: Never treated | 1 |
| Withdrew: Non-measurable | 1 |
Number of participants who survived progression-free for more than 6 months.
| participants | Treatment (Temsirolimus) |
|---|---|
| 6 Month Progression-free Survival (PFS) | 13 |
Number of participants who experienced an objective tumor response up to 5 years. Per RECIST version 1.0 criteria: each target lesion must be \>= 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or \>= 10 mm when measured by spiral CT. Complete Response is a disappearance of all target and non-target lesions. Partial Response is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions, taking as reference the baseline sum of LD. Increasing Disease is at least a 20% increase in the sum of LD of target lesions, taking as references the smallest sum LD or the appearance of new lesions.
| participants | Treatment (Temsirolimus) |
|---|---|
| Partial Response | 5 |
| Stable Disease | 22 |
| Increase Disease | 21 |
| Indeterminate | 6 |
| Participants | Grade 1 (CTCAE v3.0) | Grade 2 (CTCAE v 3.0) | Grade 3 (CTCAE v 3.0) | Grade 4 (CTCAE v 3.0) | Grade 5 (CTCAE v 3.0) |
|---|---|---|---|---|---|
| Leukopenia | 14 | 14 | 0 | 0 | 0 |
| Thrombocytopenia | 18 | 5 | 0 | 0 | 0 |
| Neutropenia | 6 | 12 | 1 | 0 | 0 |
| Anemia | 20 | 19 | 3 | 0 | 0 |
| Other hematologic | 0 | 2 | 0 | 0 | 0 |
| Allergy/Immunology | 1 | 0 | 0 | 0 | 0 |
| Auditory/Ear | 1 | 0 | 0 | 0 | 0 |
| Cardiac | 3 | 1 | 1 | 0 | 0 |
| Coagulation | 2 | 1 | 0 | 0 | 0 |
| Constitutional | 23 | 15 | 4 | 1 | 0 |
| Dermatologic | 24 | 10 | 1 | 0 | 0 |
| Nausea | 19 | 2 | 2 | 0 | 0 |
| Vomiting | 2 | 3 | 1 | 0 | 0 |
| Gastrointestinal | 16 | 19 | 6 | 0 | 0 |
| Genitourinary/Renal | 4 | 0 | 1 | 0 | 0 |
| Hemorrhage | 5 | 0 | 0 | 0 | 0 |
| Infection | 0 | 5 | 2 | 0 | 0 |
| Lymphatics | 3 | 1 | 1 | 0 | 0 |
| Metabolic | 17 | 12 | 8 | 0 | 0 |
| Musculoskeletal | 2 | 0 | 1 | 0 | 0 |
| Neurosensory | 6 | 2 | 0 | 0 | 0 |
| Other Neurological | 5 | 1 | 0 | 0 | 0 |
| Ocular/Visual | 1 | 0 | 0 | 0 | 0 |
| Pain | 13 | 7 | 6 | 0 | 0 |
| Pulmonary | 17 | 5 | 4 | 0 | 0 |
| Sexual/Reproductive | 1 | 0 | 0 | 0 | 0 |
| Vascular | 0 | 0 | 0 | 1 | 0 |
Progression is defined according to RECIST v1.0 as at least a 20% increase in the sum of LD target lesions taking as reference the smallest sum LD recorded since study entry, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, global deterioration in health status attributable to the disease requiring a change in therapy without objective evidence of progression, or unequivocal progression of existing non-target lesions.
| months | Treatment (Temsirolimus) |
|---|---|
| Duration of Progression-free Survival | 3.19 (1.74 to 5.82) |
Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
| months | Treatment (Temsirolimus) |
|---|---|
| Duration of Overall Survival | 11.60 (6.83 to 22.83) |
| participants | Treatment (Temsirolimus) |
|---|---|
| Disease Progression | 37 |
| Refused Further Treatment | 5 |
| Toxicity as permitted | 8 |
| Other | 3 |
| Unspecified | 1 |
Patients alive or dead after 24 months from time of study entry
| participants | Treatment (Temsirolimus) |
|---|---|
| Alive without disease progression | 5 |
| Alive with disease progression | 19 |
| Dead from disease | 29 |
| Dead from neither treatment nor disease | 1 |
Collected over All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Temsirolimus) | — | 5/54 (9.3%) | 44/54 (81.5%) |
| Event | Treatment (Temsirolimus) |
|---|---|
| Obstruction, Gi - Small Bowel NosGastrointestinal disorders | 5/54 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/54 |
| Thrombosis/Thrombus/EmbolismVascular disorders | 2/54 |
| FatigueGeneral disorders | 1/54 |
| InsomniaGeneral disorders | 1/54 |
| Death No Ctcae Term - Disease Progression NosGeneral disorders | 1/54 |
| IleusGastrointestinal disorders | 1/54 |
| DehydrationGastrointestinal disorders | 1/54 |
| CreatinineMetabolism and nutrition disorders | 1/54 |
| HyponatremiaMetabolism and nutrition disorders | 1/54 |
| Event | Treatment (Temsirolimus) |
|---|---|
| HemoglobinBlood and lymphatic system disorders | 44/54 |
| FatigueGeneral disorders | 43/54 |
| Cholesterol,serum HighMetabolism and nutrition disorders | 30/54 |
| LeukocytesBlood and lymphatic system disorders | 28/54 |
| NauseaGastrointestinal disorders | 28/54 |
| HypertriglyceridemiaMetabolism and nutrition disorders | 28/54 |
| RashSkin and subcutaneous tissue disorders | 25/54 |
| PlateletsBlood and lymphatic system disorders | 24/54 |
| DiarrheaGastrointestinal disorders | 24/54 |
| AnorexiaGastrointestinal disorders | 22/54 |
Number of eligible and evaluable participants
| Age, Continuous(years) | Treatment (Temsirolimus) |
|---|---|
| Mean | 62.1 ± 13.0 |
| Age, Customized(participants) | Treatment (Temsirolimus) |
|---|---|
| 20-29 years | 2 |
| 40-49 years | 7 |
| 50-59 years | 15 |
| 60-69 years | 11 |
| 70-79 years | 16 |
| 80-89 years | 3 |
| Sex: Female, Male(Participants) | Treatment (Temsirolimus) |
|---|---|
| Female | 54 |
| Male | 0 |
| Region of Enrollment(participants) | Treatment (Temsirolimus) |
|---|---|
| United States | 54 |
| International Federation of Gynecology and Obstetrics (FIGO) Recurrent/Persistent Disease(participants) | Treatment (Temsirolimus) |
|---|---|
| Number | 54 |
| Cell Type(participants) | Treatment (Temsirolimus) |
|---|---|
| Adenocarcinoma, unspecified | 8 |
| Clear Cell Carcinoma | 3 |
| Endometrioid Adenocarcinoma | 4 |
| Serous Adenocarcinoma | 39 |
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