Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Paclitaxel

Cyclophosphamide

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

G-CSF

Elise C Kohn, M.D.

A supra-additive cytotoxic effect was seen when CAI and paclitaxel were given to human ovarian cancer cells sequentially in tissue culture. We have demonstrated that CAI given for 8 days followed by paclitaxel is reasonably well tolerated and that paclitaxel administration causes a dose-dependent increase in CAI plasma concentration. CAI is a cytostatic drug and continuous exposure is needed. This study will evaluate the combination of continuously administered CAI with three-weekly paclitaxel.

A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer

National Cancer Institute (NCI)

Blood and Lymph Conditions

Immune System Diseases

Symptoms and General Pathology

Leukemia

Leukemia, Lymphoid

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Rituximab

Lenalidomide

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Lenalidomide starting at a low dose and escalated based on patient tolerability 21 days of every cycle. Rituximab at 375mg/m2 administered following the first 21 days of lenalidomide monotherapy, continued weekly throughout cycle 2, and then every 4 weeks for subsequent cycles. Each patient may receive up to a maximum of 7 cycles of treatment if no progressive disease or significant toxicity.

Lenalidomide and Rituximab

Danelle F James, M.D.

Mary Carpenter

Jamie N Gould

Danelle F James

Thomas J Kipps, M.D., Ph.D.

Evgeny Mikler, P.A.

Clinical Trials Office - Dana-Farber/Harvard Cancer Center

Jennifer R Brown, M.D.,Ph.D

Nancy Driscoll, RPA-C

Kanti Rai, M.D.

Clinical Trials Office - OSU Comprehensive Cancer Center

Michael Grever, M.D.

John Byrd, M.D.

Thomas Lin, M.D.

Susan C Smith

Clinical Trials Office

William G Wierda, M.D., Ph.D.

Michael J Keating, M.D., B.S.

Thomas J Kipps, M.D., Ph.D

The study is a two-arm, multi-center trial of Revlimid® and Rituximab, for the frontline treatment of patients with Chronic Lymphocytic Leukemia (CLL) designed and conducted by the CLL Research Consortium (CRC). The purpose of this study is to determine the response rate of the combination of Revlimid® and Rituximab in previously untreated CLL patients in two arms- those aged 65 years and above and those younger than 65. Secondary objectives will evaluate the safety of the combination of Revlimid® and Rituximab, response duration, improvement in hematologic parameters, and the significance of the tumor flare reaction. All patients will have assessment of known prognostic factors for CLL as well as novel prognostic factors will be evaluated for predicting response to treatment. Biologic corollary studies are designed to evaluate the mechanism of Revlimid® in CLL and the combination of Revlimid® and Rituximab.

The CLL Research Consortium (CRC) is conducting a two-arm, multi-center phase II trial of Revlimid® and rituximab for the first-line treatment of patients with CLL.

Revlimid® (lenalidomide) a derivative of thalidomide with immune-modulating properties. Revlimid® is FDA approved for treatment of relapsed multiple myeloma and 5q- myelodysplastic syndrome. Revlimid® has promising clinical activity in relapsed CLL in two early clinical trials. However, the mechanism(s) whereby Revlimid® is active in CLL is unknown. Rituximab (Rituxan®) is a protein that binds to CD20 expressed on normal and leukemia B cells. Rituximab is FDA approved for the treatment of lymphoma and is used commonly for the treatment of CLL. The purposes of this study are to evaluate the safety and activity of the combination of Revlimid® and rituximab in CLL, elucidate the mechanism of Revlimid® in CLL, and to assess whether prognostic factors might predict those patients likely to benefit from this therapy in the future.

As older patients are commonly under-represented in CLL clinical trials and are less tolerable of frontline therapy that utilizes combinations of fludarabine and cyclophosphamide the trial has two arms; one to specifically assess for the tolerability of the regimen in older subjects.

The primary objective of this study is to determine the response rate of the combination of Revlimid® and Rituximab in previously untreated CLL patients in two arms- those aged 65 years and above and those younger than 65. Secondary objectives will evaluate the safety of the combination of Revlimid® and Rituximab, response duration, improvement in hematologic parameters, activity of the combination in high-risk CLL subsets, and the significance of the tumor flare reaction.

All patients will have baseline assessment of known CLL prognostic factors including: immunoglobulin variable heavy chain (IgVH) gene mutational status, interphase cytogenetics, intracellular ZAP-70 expression, and CD38 expression through the CRC tissue core. These known prognostic features in CLL together with novel prognostic factors will be evaluated for the ability to predict response to treatment with Revlimid® and the combination of Revlimid® and Rituximab. Extensive biologic corollary studies are designed to evaluate the mechanism of Revlimid® in CLL, the impact of Revlimid® on the CLL microenvironment, and Revlimid®'s impact on and rituximab mediated cytotoxicity.

All patients will receive the same treatment. Revlimid® will be started at a low dose and slowly escalated based on patient tolerability. Rituximab will be administered following 21 days of Revlimid® monotherapy. Patients will continue treatment for up to 7 cycles unless there is toxicity or progressive disease. There are three planned response assessments for the subjects: a single agent Revlimid® response assessment prior to the addition of rituximab, after 3 cycles of treatment, and following all the therapy.

Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)

A Two-Arm, Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment in Patients With B-cell Chronic Lymphocytic Leukemia (CLL)

Celgene Corporation

Chronic Lymphocytic Leukemia Research Consortium

Thomas J. Kipps, M.D., Ph.D.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Oxaliplatin

Bevacizumab

Capecitabine

Cetuximab

Antimetabolites

Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle

Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle

bevacizumab

Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle

cetuximab

Oxaliplatin 130mg/m2 IV day 1 every 21 days

Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Steven Cohen, MD

The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.

Research has shown that the more drug treatments patients with cancer of the colon or rectum receive, the longer they live. One uses the drugs capecitabine and oxaliplatin which all patients on this study will receive. Bevacizumab is an antibody which blocks blood flow to tumors and increases how long patients with colorectal cancer live. However, it can increase the risk of stroke and heart attack. Bevacizumab is currently a standard part of treatment for colorectal cancer. Cetuximab is an antibody which blocks a protein called EGFR which shrinks colorectal cancer. It may be helpful with initial chemotherapy and with bevacizumab. One goal of this study is to find out the response rate (chance of tumor shrinking) with two treatments for colorectal cancer. All patients will get capecitabine, oxaliplatin and cetuximab. Half will receive bevacizumab. All drugs in this study are approved to treat colorectal cancer. This research study is being done to find the best, safest way to combine these therapies.

Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab

Phase II Study of the Combination of Cetuximab, Capecitabine, and Oxaliplatin With Out Without Bevacizumab as Initial Therapy for Metastatic Colorectal Cancer

Objective response rate calculated by the proportion of overall response: CR+PR. Patients were categorized by one of the following (1-4 per RECISTv1.0 criteria on CT, MRI, x-ray; 4-9 considered failure to respond/disease progression):

1. complete response (CR): Disappearance of all lesions
2. partial response (PR): \>=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL
3. stable disease (SD): Neither PR, PD, or CR
4. progressive disease (PD): \>=20% increase in the SoL; from smallest SoL. Or appearance of new lesion
5. early death from malignant disease
6. early death from toxicity
7. early death from other cause

9) unknown (not assessable, insufficient data)

Per Response Evaluation Criteria In Solid Tumors (RECISTv1.0) assessed by CT, MRI, x-ray scan:

Complete response (CR): Disappearance of all lesions Partial response (PR): \>=30% decrease in the sum of the longest diameter of target lesions (SoL); from baseline SoL Stable disease (SD): Neither PR, PD, or CR Progressive disease (PD): \>=20% increase in the SoL; from smallest SoL. Or appearance of new lesion

Follow-up for survival to be done at 3 month intervals for 2 years, then 6 month intervals for up to 5 years from study registration

Fox Chase Cancer Center

Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle

Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle

Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Bevacizumab: 7.5mg/kg IV day 1 of each 21 day cycle

Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab

Cetuximab: 400 mg/m2 initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle

Oxaliplatin: 130mg/m2 IV day 1 of each 21 day cycle

Capecitabine: 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Cetuximab, Oxaliplatin, Capecitabine

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Steven Cohen

Overall response

Complete response

Partial response

Stable disease

One patient in Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab Arm was not evaluable for response due to patient discontinuing after experiencing a hypersensitivity reaction to cetuximab during the first treatment.

Objective Response Rate (ORR)

Time to Progression (TTP)

Overall Survival

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Multi-Institutional Phase II Study of Cyclophosphamide, Paclitaxel, Cisplatin With G-CSF for Patients With Newly Diagnosed Advanced Stage Ovarian Cancer	NCT00001426	Ovarian Neoplas...	Cyclophosphamid... Paclitaxel Cisplatin G-CSF	-	National Institutes of Health Clinical Center (CC)
Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)	NCT00628238	Chronic Lymphoc... CLL Untreated Front-line First-Line Initial Therapy	Lenalidomide an... Lenalidomide an...	-	Chronic Lymphocytic Leukemia Research Consortium
Multi-center Trial of Revlimid® and Rituximab, for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL)	NCT00628238	Chronic Lymphoc... CLL Untreated Front-line First-Line Initial Therapy	Lenalidomide an... Lenalidomide an...	-	Chronic Lymphocytic Leukemia Research Consortium
Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab	NCT00321100	Colorectal Neop...	bevacizumab cetuximab Oxaliplatin Capecitabine	18 Years -	Fox Chase Cancer Center

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