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PROVE A Randomized Phase II Trial of Standard Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer

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Trial Information

PROVE A Randomized Phase II Trial of Standard Carboplatin-based Chemotherapy With or Without Panitumumab in Platinum-sensitive Recurrent Ovarian Cancer

Inclusion Criteria:

- Female patients with pretreated epithelial ovarian cancer, primary peritoneal
carcinomatosis or fallopian tube cancer with histological confirmation of the tumor

- Wild-type k-ras status

- Patients must have pretreated platinum-sensitive ovarian cancer with recurrence more
than 6 months after completion of a platinum-containing regimen

- Presence of at least one measurable or non-measurable disease (e.g. malignant
ascites) following RECIST criteria by radiologic evaluation OR histological
confirmation of recurrence by biopsy. The presence of non-measurable lesions only
requires in addition a 2-fold increase of CA-125 elevation above normal lab value
(confirmed by two measurements).

- No more than 2 prior treatment regimens for these epithelial cancers

- Age > 18 years.

- ECOG Performance Status of 0 or 1

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements to be conducted within 7 days prior to screening:

- Hemoglobin > 9.0 g/dl

- Leukocyte count >3.000/mm3 ; absolute neutrophil count (ANC) >1.500/mm3

- Platelet count ≥ 100.000/μl

- Total bilirubin < 1,0 times the upper limit of normal

- ALT and AST < 2,5 x upper limit of normal (< 5 x upper limit of normal for
patients with liver involvement of their cancer)

- Alkaline phosphatase < 4 x ULN

- PT-INR/PTT < 1.5 x upper limit of normal [Patients who are being therapeutically
anticoagulated with an agent such as coumarin or heparin will be allowed to
participate provided that no prior evidence of underlying abnormality in these
parameters exists.]

- Serum creatinine < 1.5 x upper limit of normal and creatinine clearance > 50

- Magnesium ≥ lower limit of normal; calcium ≥ lower limit of normal

- Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

- Clinically significant cardiovascular disease (incl. myocardial infarction, unstable
angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) ≤ 1 year before enrolment.

- History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or
evidence of interstitial lung disease on baseline chest CT scan.

- History of HIV infection or chronic hepatitis B or C

- Active clinically serious infections (> grade 2 NCI-CTC version 3.0)

- Pre-existing neuropathy > grade 1 (NCI CTCAE), except for loss of tendon reflex

- Prior radiological or clinical evidence of CNS metastases including previously
treated, resected, or asymptomatic brain lesions or leptomeningeal involvement by
head CT scan or MRI

- Patients with seizure disorder requiring medication (such as steroids or

- History of organ allograft

- Patients with evidence or history of bleeding diathesis

- Patients undergoing renal dialysis

- Previous or concurrent cancer that is distinct in primary site or histology from the
cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal
cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer curatively
treated > 3 years prior to study entry.

- Patients in a closed institution according to an authority or court decision

- Any condition that is unstable or could jeopardize the safety of the patient and
their compliance in the study

Excluded therapies and medications, previous and concomitant:

- Anticancer chemotherapy within 4 weeks prior to study entry.

- Prior anti-EGFR therapy

- Radiotherapy during study or within 4 weeks of start of study drug. (Palliative
radiotherapy of non-target lesions will be allowed) and prior radiotherapy of > 25%
of the bone marrow

- Major surgery within 4 weeks of start of study

- Autologous bone marrow transplant or stem cell rescue within 12 months of study

- Investigational drug therapy outside of this trial during or within 4 weeks of study

- Substance abuse, medical, psychological or social conditions that may interfere with
the patient's participation in the study or evaluation of the study results

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) rate after 12 months.

Outcome Description:

PFS is defined as the time from randomisation to the time of disease progression or relapse (according to RECIST, not CA-125 only!) or death, or to the date of last tumor assessment without any such event (censored observation).

Outcome Time Frame:

12 month

Safety Issue:


Principal Investigator

Jalid Sehouli, MD (Prof. Dr. med.)

Investigator Role:

Principal Investigator

Investigator Affiliation:

Frauenklinik Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum


Germany: Paul-Ehrlich-Institut

Study ID:




Start Date:

October 2011

Completion Date:

July 2015

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • fallopian cancer
  • recurrent
  • platinum-sensitive
  • KRAS-Wildtype
  • Ovarian Neoplasms