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Phase I Study of CCI-779 (NSC 683864, IND #61010) in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumours


Phase 1
18 Years
N/A
Not Enrolling
Both
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

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Trial Information

Phase I Study of CCI-779 (NSC 683864, IND #61010) in Combination With Carboplatin and Paclitaxel in Patients With Advanced Solid Tumours


PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) and recommended phase II dose of temsirolimus,
carboplatin, and paclitaxel in patients with advanced solid tumors.

SECONDARY OBJECTIVES:

I. Determine the frequency and severity of toxic effects of this regimen in these patients.

II. Document any evidence of objective antitumor activity of this regimen in patients with
measurable disease.

III. Determine the pharmacokinetic profile of carboplatin and paclitaxel alone, temsirolimus
alone, and carboplatin, paclitaxel, and temsirolimus in combination in these patients.

OUTLINE: This is a multicenter, open-label, dose-escalation study. Patients receive
treatment in either part A or part B.

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.

Cohorts of 3-6 patients in parts A and B receive escalating doses of temsirolimus,
carboplatin, and paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity. The recommended phase II dose (RPTD) is the dose that is one dose
level below the MTD. Once the RPTD is determined in part A, patients are enrolled in part B.
An expanded cohort of up to 10 patients with endometrial or ovarian cancer are treated at
the RPTD determined in part B (final RPTD).

After completion of study treatment, patients are followed at 4 weeks and then every 3
months thereafter.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Recommended phase II dose of temsirolimus, carboplatin, and paclitaxel

Outcome Time Frame:

Up to 3 years

Safety Issue:

No

Principal Investigator

Amit Oza

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCIC Clinical Trials Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00691

NCT ID:

NCT00408655

Start Date:

February 2007

Completion Date:

Related Keywords:

  • 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
  • Carcinoma
  • Neoplasms, Germ Cell and Embryonal
  • Adenoma
  • Germinoma
  • Ovarian Neoplasms
  • Neoplasms
  • Endometrial Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Sarcoma

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