Cixutumumab and Temsirolimus in Treating Patients With Metastatic Prostate Cancer

NCT01026623 | Completed Phase 1 Results

• 6 other identifiers: NCI-2011-01406CDR000065906409-1178147P30CA008748U01CA069856
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 4

Brief Summary

This phase I/II trial is studying the side effects of giving cixutumumab together with temsirolimus and to see how well it works in treating patients with metastatic prostate cancer. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with temsirolimus may kill more tumor cells.

Conditions

Hormone-Resistant Prostate Cancer; Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• cTTP

  Defined as the time from the first day of treatment to the earliest one of the following: tumor progression by RECIST; unequivocal evidence of progression by bone scan (at least two new lesions with confirmation at subsequent imaging); new skeletal events; symptomatic progression; or other clinical events attributable to prostate cancer that necessitate major interventions. This Outcome Measure is related to the Phase II portion of the Trial, which did not occur. Therefore, there is no data to report.

  Up to 4 weeks after completion of study treatment

• Tumor Response Rate

  Defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) and/or the proportion of patients who achieve a greater than 50% reduction in serum PSA compared to baseline.

  Up to 4 weeks after completion of study treatment

Secondary Outcomes (5)

• Change in PSA Doubling Time

  Week 1, Week 5, Week 9, Week 13, Week 17, Week 21 and Week 25

• Duration of Effect

  From the time of first dose until the time of progression, assessed up to 4 weeks after completion of study treatment

• Maximal Percentage Change in Serum PSA as Compared to Week 12 Versus Baseline

  From baseline to week 12

• Progression-free Survival

  From the time of first dose until objective tumor progression or death, assessed up to 4 weeks after completion of study treatment

• Rate of Adverse Events According to NCI CTCAE Version 4.0

  Up to 4 weeks after completion of study treatment

Study Arms (1)

Treatment (cixutumumab, temsirolimus)

EXPERIMENTAL

Patients receive cixutumumab IV over 60-70 minutes and 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.

Biological: Cixutumumab; Other: Diagnostic Laboratory Biomarker Analysis; Drug: Temsirolimus

Interventions

Cixutumumab BIOLOGICAL

Given IV

Also known as: Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12, IMC-A12

Treatment (cixutumumab, temsirolimus)

Diagnostic Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (cixutumumab, temsirolimus)

Temsirolimus DRUG

Given IV

Also known as: CCI-779, CCI-779 Rapamycin Analog, Cell Cycle Inhibitor 779, Rapamycin Analog, Rapamycin Analog CCI-779, Torisel

Treatment (cixutumumab, temsirolimus)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed adenocarcinoma of the prostate
• Distant metastases evaluable by radionuclide bone scan, CT scan, or magnetic resonance imaging (MRI) within the past 28 days
• Evidence of progressive disease during androgen-deprivation therapy (including a trial of antiandrogen-withdrawal therapy), as defined by ≥ 1 of the following criteria:
• Progressive measurable disease using conventional solid tumor criteria
• Bone scan progression, defined as ≥ 2 new lesions on bone scan
• Increasing PSA, defined as ≥ 2 consecutive rising PSA values over a reference value taken ≥ 1 week apart (the third PSA value must be greater than the second PSA value, if not, a fourth PSA value must be greater than the second PSA value)
• Castrate levels of serum testosterone (i.e., ≤ 50 ng/dL)
• No known brain metastases
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
• Life expectancy \> 6 months
• Leukocytes ≥ 3,000/μL
• Absolute neutrophil count (ANC) ≥ 1,500/μL
• Platelet count ≥ 100,000/μL
• Hemoglobin ≥ 9 g/dL
• Total bilirubin ≤ 2 times upper limit of normal (ULN)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cixutumumab; temsirolimus; Sirolimus

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Limitations and Caveats

cTTP This Outcome Measure is related to the Phase II portion of the Trial, which did not occur. All patients had withdrawn from study prior to data analysis. Therefore, there is no data to report for this measure.

Results Point of Contact

• Title: Dana Rathkopf
• Organization: Memorial Sloan Kettering Cancer Center

rathkopd@mskcc.org

646-422-4379

Study Officials

• Dana Rathkopf

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 17, 2019
• Results First Posted: June 17, 2019

Record last verified: 2019-05

Locations

US (4)