Temsirolimus, Carboplatin, and Paclitaxel in Treating Patients With Advanced Solid Tumors

NCT00408655 | Completed Phase 1

• 4 other identifiers: NCI-2009-00691CDR0000652060IND.179NCIC-179
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects and best dose of temsirolimus, carboplatin, and paclitaxel in treating patients with advanced solid tumors. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving temsirolimus together with chemotherapy may kill more tumor cells.

Conditions

Ovarian Sarcoma; Ovarian Stromal Cancer; Recurrent Endometrial Carcinoma; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Stage III Endometrial Carcinoma; Stage III Ovarian Epithelial Cancer; Stage III Ovarian Germ Cell Tumor; Stage IV Endometrial Carcinoma; Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (4)

• Recommended phase II dose of temsirolimus, carboplatin, and paclitaxel

  Up to 3 years

• Safety

  Up to 3 years

• Tolerability

  Up to 3 years

• Dose-limiting toxicities

  Up to 3 years

Secondary Outcomes (1)

• Efficacy

  Up to 3 years

Study Arms (1)

Arm I

EXPERIMENTAL

PART A: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30-60 minutes on day 1 and temsirolimus IV over 30 minutes on days 8 and 15. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. PART B: Patients receive paclitaxel and carboplatin as in part A. They also receive temsirolimus IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Drug: paclitaxel; Drug: carboplatin; Drug: temsirolimus

Interventions

paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, TAX, Taxol

Arm I

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

Arm I

temsirolimus DRUG

Given IV

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

Arm I

Eligibility Criteria

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

Criteria: * Histologically confirmed solid tumors * Measurable or nonmeasurable disease: No serum tumor marker elevation as the only evidence of disease; Patients with ovarian or endometrial cancer must have measurable disease, defined as \>= 1 lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan * Advanced disease; Refractory to standard therapy OR no standard therapy is available * Carboplatin and paclitaxel considered reasonable therapeutic option * No known brain metastases * ECOG performance status 0-1 * Life expectancy \>= 12 weeks * Absolute granulocyte count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Bilirubin =\< 1.5 times upper limit of normal (ULN) * AST and ALT =\< 3 times ULN (5 times ULN if documented liver metastases) * Fasting serum cholesterol =\< 9.0 mmol/L * Fasting triglycerides =\< 4.56 mmol/L * Creatinine normal OR creatinine clearance \>= 50 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Accessible for treatment and follow up * No serious cardiovascular illness, including any of the following: myocardial infarction within the past 6 months, congestive heart failure (even if medically controlled), unstable angina, active cardiomyopathy, cardiac arrhythmia, uncontrolled hypertension * No preexisting sensory or motor neuropathy \>= grade 2 due to previous chemotherapy; Local or regional neurological findings related to previous injury or disease allowed * No hearing loss \>= grade 2 from any cause * No history of allergic reactions attributed to compounds of similar chemical or biological composition to temsirolimus * No serious illness or medical condition that would preclude study treatment including, but not limited to, any of the following: History of significant neurologic or psychiatric disorder that would impair the ability to obtain consent or limit study compliance, Active uncontrolled infection or nonhealing wounds, OR; * At least 4 weeks since prior radiotherapy (except low-dose, palliative radiotherapy) and recovered * At least 4 weeks since prior chemotherapy and recovered * No more than 2 prior chemotherapy regimens * Prior therapy with carboplatin and/or paclitaxel allowed provided the patient has no persistent related toxicity \>= grade 1 AND retreatment with the combination is clinically indicated (e.g., second-line therapy for ovarian cancer with \> 6-month treatment-free interval) * At least 21 days since prior major surgery and recovered * No prior mTOR inhibitor * No concurrent prophylactic hematopoietic colony-stimulating factors * No other concurrent anticancer therapy or investigational agents * Active peptic ulcer disease, Any other medical condition that might be aggravated by treatment

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute of Canada Clinical Trials Group

Kingston, Ontario, K7L 3N6, Canada

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Paclitaxel; Taxes; Carboplatin; temsirolimus; Sirolimus

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Coordination Complexes; Macrolides; Lactones

Study Officials

• Amit Oza

  Canadian Cancer Trials Group

  PRINCIPAL INVESTIGATOR

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 6, 2006
• First Posted: December 7, 2006
• Study Start: February 1, 2007
• Primary Completion: January 1, 2012
• Last Updated: June 19, 2014

Record last verified: 2014-06

Locations

CA (1)