Neoadjuvant Bevacizumab and Carboplatin Followed by Concurrent Bevacizumab, Carboplatin and Radiotherapy in the Primary Treatment of Cervix Cancer

NCT00600210 | Withdrawn Phase 2 DMC

• 1 other identifier: AVF3963s
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is designed to study the safety and efficacy of the combination of carboplatin, bevacizumab, and pelvic radiation therapy. Rationale for substituting cisplatin with carboplatin: Five landmark trials in cervical cancer prompted the National Cancer Institute in February of 1999 to issue a clinical announcement stating that "strong consideration should be given to adding concurrent chemotherapy in the treatment of invasive cervical cancer". The chemotherapeutic agent which was a common denominator to all 5 trials was cisplatin, and ever since it has become part of the standard of care for the treatment of stage IIB, III, and IVA cervical cancers. In addition, chemoradiotherapy with cisplatin is also considered one of the standard treatment options for IB2 and IIA tumors greater than 4 cm in diameter. The most recent Gynecologic Oncology Group protocols for cervical cancer have used cisplatin and radiation therapy as in two of the five landmark trials. However, the benefit in survival given by cisplatin has not been without toxicity. In summary, in the trial by Keys 35% of patients receiving cisplatin and radiotherapy experienced moderate or severe toxicities. In the one by Rose, only 49 % completed the intended 6 cycles of chemotherapy. Based on the toxicity profile of cisplatin, Higgins performed a phase II study of concurrent carboplatin with pelvic radiation therapy in the primary treatment of cervix cancer. He demonstrated the ability to administer carboplatin with concurrent radiation therapy with significantly less toxicity and with 94 % of the planned treatments delivered. A comprehensive analysis of the literature from 1998 which compared the efficacy of carboplatin versus cisplatin in solid tumors concluded that for ovarian cancer and lung cancer the effectiveness of carboplatin was comparable to cisplatin, while for germ cell tumors, bladder cancer, and head and neck cancer cisplatin appeared superior. There was no mention of cervical cancer in this review, since at present there is no phase III trial comparing carboplatin versus cisplatin in cervix cancer. Rationale for bevacizumab: Bevacizumab is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of vascular endothelial growth factor (VEGF) which stimulates tumor and tumor blood vessel growth. Targeting VEGF with bevacizumab could potentially be of benefit in cervical cancer patients by starving the tumor's blood supply and potentially enhancing the effect of radiotherapy and carboplatin chemotherapy.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• To determine the safety of the proposed treatment in this patient population.

  5 years

Secondary Outcomes (1)

• Progression Free Survival

  5 years

Study Arms (1)

I

EXPERIMENTAL

Drug: Bevacizumab; Drug: Carboplatin; Radiation: Radiation Therapy

Interventions

Bevacizumab DRUG

Bevacizumab will be delivered intravenously on day -7 at a dose of 10 mg/kg followed by carboplatin AUC 2.0 intravenously. This will allow therapy to start one week before starting radiotherapy to assess the initial tolerability of the combination without having radiation as a confounding factor, to start treatment while the patient's radiation is being planned, and to possibly optimize the tumor vasculature and allow optimal carboplatin delivery by the time chemoradiotherapy starts. Thereafter, bevacizumab will be given intravenously at 10 mg/kg every two weeks. Carboplatin will be given intravenously weekly at AUC 2.0. On weeks where both drugs are given, bevacizumab will be given first since it could help sensitize the tumor cells to carboplatin.

I

Carboplatin DRUG

Bevacizumab will be delivered intravenously on day -7 at a dose of 10 mg/kg followed by carboplatin AUC 2.0 intravenously. This will allow therapy to start one week before starting radiotherapy to assess the initial tolerability of the combination without having radiation as a confounding factor, to start treatment while the patient's radiation is being planned, and to possibly optimize the tumor vasculature and allow optimal carboplatin delivery by the time chemoradiotherapy starts. Thereafter, bevacizumab will be given intravenously at 10 mg/kg every two weeks. Carboplatin will be given intravenously weekly at AUC 2.0. On weeks where both drugs are given, bevacizumab will be given first since it could help sensitize the tumor cells to carboplatin.

I

Radiation Therapy RADIATION

Whole pelvis will be treated to a total dose of 45 Gy in 5 weeks. Cesium will be used with standard intracavitary systems preferably in two intracavitary applications. An effort should be made to deliver a minimum cumulative external and intracavitary dose to Point A of 85 Gy in 2 insertions.

I

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 IB2 and IIA tumors greater than 4 cm in diameter, IIB, IIIB without hydronephrosis or non-functioning kidney, and IVA without invasion to the bladder or rectum, primary, previously untreated, and histologically confirmed invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.
• Negative, non-suspicious para-aortic nodes determined by CT lymphangiogram, MRI or lymphadenectomy.
• Adequate bone marrow function: ANC greater ≥ 1,500/mm3, platelets ≥ 100,000/mm3.
• Adequate renal function: serum creatinine ≤ 1.5 mg/100 mL.
• Adequate hepatic function: bilirubin less than or equal to 1.5 x upper limit of normal (ULN) and SGOT and alkaline phosphatase less than or equal to 3 x ULN.
• Zubrod Performance Status of 0 or 1
• Patients of childbearing potential must have a negative serum pregnancy test within14 days of enrolling in this study and use an effective form of contraception during the study period.
• Patients who are medically suitable for treatment with radical intent using concurrent chemotherapy and pelvic radiation.

You may not qualify if:

• Patients with Stage IA, IB1, IB2 and IIa tumors less than 4 cm in diameter, IIIA or IVB disease.
• Patients who have known metastases to para-aortic or scalene nodes or metastases to other organs outside the radiation field at the time of the original clinical and surgical staging.
• Extensive tumor preventing intracavitary irradiation.
• Distal vaginal involvement or any disease such that an interstitial implant might be necessary
• Previous pelvic or abdominal radiation, cytotoxic chemotherapy, or previous therapy of any kind for this malignancy.
• Patients who might require an emergency surgical procedure to relieve hydronephrosis, or who are at risk of perforating the bladder and might require surgery.
• Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields
• Life expectancy of less than 12 weeks
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study.
• Septicemia or severe infection
• Patients who have circumstances that will not permit completion of this study or the required follow-up.
• Patients who are pregnant at the time of diagnosis and do not wish pregnancy termination prior to initiation of treatment.
• Other concomitant malignancies, with the exception of nonmelanoma skin cancer, who had (or have) any evidence of other cancer present within the last 5 years.
• Inadequately controlled hypertension (defined as systolic blood pressure \>150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)
• Any prior history of hypertensive crisis or hypertensive encephalopathy

Sponsors & Collaborators

• Leo W. Jenkins Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

East Carolina University School of Medicine

Greenville, North Carolina, 27834, United States

Location

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MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Bevacizumab; Carboplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Therapeutics

Study Officials

• Gloria Frelix, MD

  East Carolina University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: January 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 23, 2017

Record last verified: 2017-08

Locations

US (1)