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A Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)
This study is not yet open for participant recruitment.
Verified by OSI Pharmaceuticals, April 2009
First Received: April 6, 2009   Last Updated: April 24, 2009   History of Changes
Sponsored by: OSI Pharmaceuticals
Information provided by: OSI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00889382
  Purpose

This is a multi-center, randomized, open-label, phase I/II study of continuous weekly paclitaxel and escalating doses of intermittent or continuous OSI-906 in patients with recurrent/relapsed ovarian and other solid tumors.


Condition Intervention Phase
Solid Tumors
Ovarian Cancer
Drug: OSI-906 and Paclitaxel
Phase I
Phase II

MedlinePlus related topics: Cancer Ovarian Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: A Phase I/II Study Evaluating Intermittent and Continuous OSI-906 and Weekly Paclitaxel in Patients With Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)

Further study details as provided by OSI Pharmaceuticals:

Primary Outcome Measures:
  • MTD, RP2D, CA125 response rate [ Time Frame: 28 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response, PFS, OS, Safety, PK, PD [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 169
Study Start Date: July 2009
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Phase 2: Arm A - Intermittent OSI-906 QD + weekly paclitaxel
Drug: OSI-906 and Paclitaxel
Intermittent OSI-906 in combination + weekly paclitaxel
2: Experimental
Phase 2: Arm B - Continuous OSI-906 BID + weekly paclitaxel
Drug: OSI-906 and Paclitaxel
OSI-906 in combination + weekly paclitaxel
3: Experimental
Phase 2: Arm C - Weekly Paclitaxel
Drug: OSI-906 and Paclitaxel
OSI-906 in combination + weekly paclitaxel

Detailed Description:

The phase 1 dose escalation portion will establish the maximum tolerated dose (MTD) in patients with advanced solid tumors. Once the recommended phase 2 dose (RP2D) is established for both schedules, the phase 2 study will begin. Patients with relapsed/recurrent epithelial ovarian cancer will be randomized 1:1:1 to 3 treatment groups.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed epithelial ovarian carcinoma. Patients with fallopian or peritoneal cancer will also be eligible.
  • Patients with any solid tumor that may be treated with weekly paclitaxel will be eligible for the phase 1 portion.
  • For the phase 2 portion, patients must have elevated CA125 levels evaluable/assessable according to GCIG criteria (ie, > 70 U/mL) documented by 2 measurements at least 1 week apart [30 ].
  • Patients must have progressive disease as documented by a doubling of CA125 or by RECIST criteria.
  • Age >= 18 years.
  • ECOG PS 0 -1
  • Predicted life expectancy >= 12 weeks.
  • Patients may have had prior therapy, providing the following conditions are met:
  • Chemotherapy: Prior chemotherapy must have been completed at least 3 weeks prior to study enrollment (6 weeks for mitomycin C, nitrosoureas or high-dose carboplatin [>= 600 mg/m²]
  • and 4 weeks for investigational drugs) and the patient should have recovered from any drug-related toxicities (with the exception of grade 1 neuropathy and or alopecia).
  • Phase 1: While there is no limit on the number of prior regimens for patients entered into the phase 1 portion, any prior taxane therapy must have been administered on a 3 week schedule.
  • Phase 2: Patients must have received prior chemotherapy, which must have contained a platinum and a taxane at some point. Any prior taxane therapy must have been administered on a 3 week schedule.
  • A maximum of 2 prior chemotherapy regimens are permitted. Patients must be refractory (PD during chemotherapy) or resistant (PD within six months of completing chemotherapy) to their last platinum-containing chemotherapy regimen.
  • Radiation: Patients may have had prior radiation therapy provided they have recovered from the acute, toxic effects of radiotherapy prior to registration/randomization.
  • A minimum of 21 days must have elapsed between the end of radiotherapy and registration/randomization into the study unless the radiation affected less than 25% of bone marrow.
  • Surgery: Previous surgery is permitted provided that adequate wound healing has occurred prior to registration/randomization.
  • Fasting glucose <= 150 mg/dL (8.3 mmol/L).
  • Adequate hematopoietic, hepatic, and renal function defined as follows:
  • Neutrophil count > = 1.5 x 10 ^9 /L and platelet count > = 100 x 10^9/L;
  • Bilirubin <= 1.5 x ULN;
  • AST and/or ALT <= 2.5 x ULN or < = 5 x ULN if patient has documented liver metastases; and
  • Serum creatinine < = 1.5 x ULN.
  • Patients, both males and females, with reproductive potential (ie, menopausal for less than 1 year and not surgically sterilized) must agree to practice effective contraceptive measures.
  • measures (ie, barrier methods that include condom or diaphragm, with spermicide) throughout the study.
  • Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration/randomization.
  • Patients must provide verbal and written informed consent to participate in the study.

Exclusion Criteria:

  • Diabetes mellitus currently requiring medication (eg, insulin or oral hypoglycemics).
  • During the phase 2 portion, patients with histology of abdominal adenocarcinoma of unknown origin or a diagnosis of a borderline ovarian tumor.
  • Previous or concurrent malignancies (excluding curatively treated basal or squamous cell carcinoma of the skin or cervical cancer) unless the patient has been in remission for at least 3 years.
  • History of significant cardiovascular disease unless the disease is well-controlled. Significant cardiac diseases includes second/third degree heart block; significant ischemic heart disease;
  • QTc interval > 450 msec at baseline; poorly controlled hypertension; congestive heart failure of New York Heart Association (NYHA) Class II or worse
  • (slight limitation of physical activity; comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea).
  • History of cerebrovascular accident (CVA) within 6 months prior to registration/randomization or that is not stable.
  • Prior therapy with an IGF1R inhibitor.
  • Use of drugs that have a risk of causing QT interval prolongation within 14 days prior to Day 1 dosing.
  • Known or prior hypersensitivity to taxanes or drugs containing Cremophor.
  • Gastro-intestinal abnormalities, including bowel obstruction, inability to take oral medication, requirement for intravenous (IV) alimentation,
  • active peptic ulcer or prior surgical procedures or bowel resection affecting absorption.
  • Active infection or serious underlying medical condition (including any type of active seizure disorder within 12 months prior to registration/randomization) that would impair the ability of the patient to receive protocol treatment.
  • History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent.
  • Pregnancy or breast-feeding.
  • Symptomatic brain metastases that are not stable, require steroids, are potentially life threatening, or that have required radiation within 28 days prior to registration/randomization.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drug.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889382

Contacts
Contact: OSIP Medical Information 800.572.1932 medical-information@osip.com

Locations
United States, Maryland
Johns Hopkins Kimmel Cancer Center
Baltimore, Maryland, United States, 21231
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Canada, Ontario
Hamilton Regional Cancer Center
Hamilton, Ontario, Canada, L8V 5C2
Switzerland
IOSI
Bellinzona, Switzerland
United Kingdom
University Hospital
Coventry, United Kingdom, CV2 2DX
United Kingdom, Surrey
Drug Development Unit Royal Mardsen NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
OSI Pharmaceuticals
Investigators
Study Director: David Sternberg, MD, PhD OSI Pharmaceuticals
  More Information

No publications provided

Responsible Party: OSI Pharmaceuticals ( Karsten Witt, MD, VP Clinical Development )
Study ID Numbers: OSI-906-202
Study First Received: April 6, 2009
Last Updated: April 24, 2009
ClinicalTrials.gov Identifier: NCT00889382     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by OSI Pharmaceuticals:
Ovarian Cancer
Paclitaxel
OSI-906
IGF-1R
Solid Tumors

Study placed in the following topic categories:
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Ovarian Epithelial Cancer
Recurrence
Genital Diseases, Female
Paclitaxel
Tubulin Modulators
Ovarian Cancer
Endocrinopathy
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009