Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma

NCT00093782 | Completed Phase 2 Results

• 6 other identifiers: NCI-2012-03053PHL-0216171N01CM17105N01CM17107N01CM17102
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die.

Conditions

Metastatic Gastrointestinal Carcinoid Tumor; Pulmonary Carcinoid Tumor; Recurrent Gastrointestinal Carcinoid Tumor; Recurrent Islet Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Tumor Response Rate (Defined as Partial or Complete Response as Defined by the RECIST Criteria)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Up to 8 years

Secondary Outcomes (6)

• Stable Disease Rate Defined by RECIST Criteria

  Up to 8 years

• Median Survival Time

  3

• Survival Rate

  1 year

• Response and Stable Disease

  2 months

• Number of Temsirolimus Treatment Cycle Analyzed for Toxicity

  Duration of participants treatment upto 16wks (4cycles) of treatment

Study Arms (1)

Treatment (temsirolimus)

EXPERIMENTAL

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.

Drug: temsirolimus; Other: laboratory biomarker analysis

Interventions

temsirolimus DRUG

Given IV

Also known as: CCI-779, cell cycle inhibitor 779, Torisel

Treatment (temsirolimus)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (temsirolimus)

Eligibility Criteria

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

You may qualify if:

• Patients must have histologically or cytologically confirmed neuroendocrine tumours either of carcinoid histology or a carcinoma of pancreatic islet cell origin; small cell variant, endocrine organ carcinomas, and adrenal gland malignancies (including paragangliomas) are excluded from this study
• Patients must have progressive metastatic disease defined by one of the following occurring within 6 months of study entry:
• At least a 25% increase in radiologically or clinically measurable disease
• Appearance of any new lesion or
• Deterioration in clinical status
• Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan
• Previous local therapy (e.g. chemoembolization or bland embolization) allowed if completed \> 6 weeks prior to study entry; for patients who received local therapy prior to study entry, there must be either progression of measurable disease documented within the treatment field, or must have measurable disease outside the treatment field prior to study entry
• Previous chemotherapy, investigational agents or radioactive therapies (e.g. radioactive octreotide) allowed if completed \> 4 weeks prior to study entry (\> 6 weeks if last regimen contained BCNU or mitomycin C); for patients who received systemic therapy prior to study entry, there must be documented progression of measurable disease prior to study entry
• Patients must not have disease that is currently amenable to surgery; prior surgery is allowed no less than 6 weeks prior to study entry
• Previous radiation therapy is allowed if \> 4 weeks have elapsed since delivery of a dose likely to have myelotoxic effects (e.g. ≥ 3000cGy to fields including substantial marrow)
• Life expectancy of greater than 3 months
• ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
• Leukocytes ≥ 3.0 x 10\^9/L
• Absolute neutrophil count ≥ 1.5 x 10\^9/L
• Platelets \>= 100 x 10\^9/L

You may not qualify if:

• Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• Patients may not be receiving any other investigational agents concurrently or within 4 weeks of study entry
• Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779
• Concurrent cancer from another primary site requiring treatment of any kind within the past 3 years; curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix are allowed
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Pregnant women are excluded from this study because CCI-779 is an inhibitor of mRNA translation with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CCI-779, breastfeeding should be discontinued if the mother is treated with CCI-779
• HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with CCI-779; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Princess Margaret Hospital Phase 2 Consortium

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Islet Cell

Interventions

temsirolimus; Sirolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr. Lillian Siu
• Organization: Princess Margaret Cancer Centre

lillian.siu@uhn.ca

416-946-2911

Study Officials

• Lillian Siu

  Princess Margaret Hospital Phase 2 Consortium

  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 6, 2004
• First Posted: October 8, 2004
• Study Start: December 1, 2003
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 7, 2017
• Results First Posted: December 12, 2016

Record last verified: 2016-12

Locations

CA (1)